Medical Device Design: effective treatment became possible with latest technology


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Without reliable medical producing and medical device packaging the impact of analysis and innovation by doctors and researchers all over would hardly be felt in every-day hospitals and medical offices. Whereas the science behind drugs dictates what attainable, an efficient medical producing business makes it all offered. A few years past, before the appearance of advanced Medical Device Design patients had to travel long distances to receive the treatment that might doubtless save their lives. Today, things are completely different.

Years of innovation in CPT coding guidelines have given America the technology necessary to manufacture the various medical devices and elements necessary to shrink the world for patients by delivering them the solutions they have. This technology contributed to the innovation of recent hospitals round the world, whereas additionally giving rise to a different distinctive problem: stocking them.

The medical field needs the utilization of lots of special instrumentality, and in several cases – if medical instrumentality does not have to be compelled to be disposed of straight off once use – d it’s typically terribly fragile. Due to this, the medical producing field exists to provide the very important medical packaging required round the world.

So what makes medical device packaging effective?

Protection: maybe the most important issue once it involves effective medical packaging is protection. There square measure lots of things to require into thought once it involves planning the right packaging resolution for a medical device. First, material should be elect. Will the package have to be compelled to be flexible? What are the wants for sterility? Appropriate protection ranges from the earliest style stages to final changes created to confirm the simplest attainable resolution.

Visibility: Visibility will mean the selling visibility of a product or the literal visibility of a product through packaging. Once it involves medical product packaging, marketability typically plays a smaller role thanks to the merchandise already being “purchased” by the hospital or medical workplace. However, the particular visibility of the merchandise will create a serious distinction once it involves tending professionals quickly and simply distinguishing the device or instrument they have.

Ease of use and functionality: The goal of medical device packaging is not only to guard, however to deliver. Therewith aforesaid, easy use is probably the foremost underrated feature once it involves effective medical device packaging. If it’s faithfully protected and simply specifiable, the duty is simply 0.5 done. Subsequent question to raise would be, “is it intuitive?” once it involves gap merchandise in our every-day lives, this can be an element which will not be important.

However, once the merchandise being opened may be a delicate medical device getting used in very doubtless fast surroundings, intuitively designed packaging is vital. With this in mind, actual expertise in Associate in Nursing operating theater or medical workplace will go a protracted method in guaranteeing that medical packaging will its job seamlessly.

Behind any helpful machine or device, there’s an inspiration or a plan. The researchers and scientists of FDA medical device approval initial get their thought proprietary, then the analysis is finished followed by the manufacture of the machine and eventually the device is tested before getting used publicly. The conversion of a epitome to a product needs some steps to be followed. For the conversion purpose there square measure firms concerned for that business. These firms assist you to create your device economical in such some way so it’ll be prepared for the discharge purpose within the market. Medical Device tube is finished by firms before the discharge of the merchandise. The merchandise is absolutely tested and gets the approvals once the total scrutiny.

You can contact the businesses for brand spanking new development of product. And with the support you may additionally get full get pleasure from the corporate styleers and developers who will determine the failings within the machine design and proper in line with that. So, get the right style resolution by contacting these firms for your medical device tube demand.

I am content publisher of It provides step by step guidance to getting FDA approval, medical device design, 510K clearance, FDA clearance Process and CPT coding guidelines.

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Marketing A Medical Device From GlobalComplaincePanel


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If manufacturing a medical device is one thing; marketing it is an altogether different one. It obviously goes without saying that a manufactured product is useless in itself unless it reaches the market. Marketing a medical device in the US entails having to carry out many steps, all of which need to be properly done and carried out at the appropriate time. What are the steps the FDA expects from a manufacturer of a medical device?

Subject to controls

Every medical device that is meant for marketing is bound by the general controls of the Federal Food Drug & Cosmetic (FD&C) Act. These controls are located in 21 CFR Parts 800-1299. The aim of these controls is to state the requirements that are necessary for all medical devices. These controls cover aspects relating to labeling, marketing, and performance monitoring after the device enters the market.

Marketing approval involves three steps

If a medical device has to be marketed; the first course of action is to determine whether the product is a medical device. 201(h) of the FD&C Act states the definition of what a medical device is. This is to make sure that the product developed by a manufacturer is indeed fit to be classified as a medical device. Why this step is necessary is that many medical devices also qualify as other products, such as electronic radiation emitting products.

Classifying the device

The next step is to classify the medical device. The FDA classifies medical devices into three categories: Class I, Class II and Class III medical devices. At their most basic level, this is how these classes go:

Class I consists of medical devices for which there are minimum regulatory controls and for which no approval is necessary. It follows from this definition that Class I medical devices are low-risk medical devices. The most common Class I devices that come to mind are bandages, gloves, etc.

Class II medical devices are those that require a slightly high degree of special controls in addition to general controls. Examples of this class are surgical instruments.

Class III medical devices require a high degree of FDA premarket notification and post-market surveillance, such as defibrillator for instance.

Information about the product

The third step is for the manufacturer to gather and present data and/or information necessary for submitting a marketing application, after which the firm has to get FDA clearance to market.

Whether submissions are made under 510 (K) or Post Market Approval applications, for most of these; clinical performance data is necessary if the device has to obtain approval for marketing. The manufacturer has to show that the trial was done in accordance with FDA’s Investigational Device Exemption (IDE) regulation.

Other requirements

There are premarket and post market requirements. Premarket requirements includelabeling, registration and listing. Simply put; these stages require these: The manufacturer has to ensure that labeling for the device meetsFDA’s labeling regulations. After this is done; the company has to be registered after clearance for marketing is obtained. At the time of registration, the manufacturer must also mention the type of device it plans to market. This has to be done electronically, unless the manufacturer has been granted a waiver from the FDA.

Post market requirements

The marketing of a medical device is complete once it meets post market requirements that relate to the product’s Quality System, which relates to Good Manufacturing Practices(GMPs) and Medical Device Reporting, which is essentially about adverse event reporting.

GlobalCompliancePanel is a training source that delivers diverse, high quality regulatory & compliance trainings. These trainings are simple while being relevant and cost-effective while being convenient.

GlobalCompliancePanel imparts knowledge of best practices across a broad range of user-friendly mediums such as webinars, seminars, conferences and tailored, individualized consulting. These help organizations and professionals implement compliance programs that meet regulatory demands and put business processes in place.


Boost Your Companies Efficiencey With Medical Device Recruiters.


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Cisco showed their NAC (network access control appliance) that’s been tailored for supporting networked medical devices. Pretty cool.

What exactly does a medical device recruiter do? The answer is simple. Medical device recruiters offer assistance to companies that are looking to fill a medical device job position. These recruiters specialize in matching medical device specialists to to a company that has a position to fill, by using their experience, expertise and a large database. It does not matter if a company is looking to fill one position or build an entire medical device team, medical device recruiters have the connections and expertise to get those positions filled by qualified and professional medical device specialists.

Hiring new employees can be a very time consuming and daunting task for any company. Shuffling through application after application looking for the perfect candidate with all the required skills is a huge headache. Medical device recruiters make this job quick and painless for companies.

With a database that is full of medical device specialists, the recruiter can tailor a search that is based on a companies specific needs. The way this works is the company will give the medical device recruiters information that describes what experience, skills and education is required of a job applicant. One the other side, a medical device specialist that is looking for employment will give the medical device recruiters all of the information that pertains to experience, skills and education, as well as the cities that they are willing to work. At this point, the medical device recruiters can perform a tailored search that provides matches between a company and a medical device specialist. The recruiter then will deliver a list of qualified medical device specialists that met all of the company’s requirements. All of this is usually done in a very short amount of time.

Medical device companies need sales teams and the most efficient way to hire sales people is through medical device sales recruiters. Medical device sales recruiters provide similar service as medical device recruiters, however sales recruiters concentrate in medical device sales representatives. Companies involved in medical devices know that highly developed skills and organization is a must in order to be successful. In the name of efficiency many medical device companies are outsourcing their hiring process to professional medical device recruiters and also medical device sales recruiters.

If you a medical device specialist that searching for employment, you do not need to search any further than a medical device recruiter. Taking just a few minutes to answer the recruiters questions will allow the recruiter to perform a detailed search that is based on your answers. In a short time, the recruiter will be able to match you with medical device companies that are seeking specialists with your skills. Medical device recruiters make job hunting a breeze for any specialist. Medical device sales professionals also can see the same results when using medical device sales recruiters.

If your searching for a talented medical device recruiters to find your dream job, look no further. Our medical device sales recruiters will match you with the perfect company to give your everything you desire. Visit Us Today!

The healthcare industry is a hot bed of innovation. A convergence of new technologies, connectivity, big data and analytic models are creating a multitude of opportunities to improve health outcomes and reinvent platforms for device and service businesses. Working in a regulated industry requires special considerations that can prove challenging for the uninitiated.

From concept generation to launch, this session, led by Aidan Petrie, Chief Innovation Officer of Ximedica, will provide an overview of six essential components of successful product development specific to the development of medical devices and healthcare products. We will start with a discussion around the regulatory considerations that drive many of the activities surrounding each of the development phases and then cover step-by-step each phase of development including an overview of funding milestones and potential sources. Part how-to, part know-how the aim of this short workshop is to equip anyone who is currently trying to bring a product to market or may do in the future with a high level view from experts in the field.

Ximedica is the largest product developer the country that is focused solely on the medical space. Our clients range from Fortune 30, VC’s, university incubators and everything in between.

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Medical devices and the FDA


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Medical devices constitute a very huge and complex field. Devices can range from anything between a thermometer and a pacemaker. The FDA, the US’ food and drug regulatory body, has a definition for devices. It considers a medical device as “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
o recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
o intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
o intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.”

The FDA has a stellar role in regulating the medical devices industry. It is the sole regulatory body for medical devices, a role it has assumed considering the serious health implications even a small fault in a device can cause.

What is meant by FDA approval?
An FDA approval for medical devices means that the said product is ready and certified as being ready for marketing. Any and every manufacturer has to get FDA approval for marketing adevice. It has to get this clearance through a premarket notification, or what is called 510 (K). The FDA will clear the device that has been sent to it for approval, or reject it. If the device meets the stringent criteria set by the FDA for approval, then it is considered an approved.

What a cleared or approved medical device means is that the FDA deems it to be at least as safe as another device that has already been marketed and is put to the same use. The application for this clearance should have proof to show that the present medical device, whose clearance is sought, exhibits this quality.

Is 510(K) necessary for all medical devices?
The answer is ‘no’. Not all devices need to go through a 510(K) process. Devices that are classified under, meaning those that pose the least risk to the user do not need 510 (K). Only a few Class II and all Class III devices, which entail a higher risk to the user, are subject to a 510 (K) premarket approval (PMA).

What are general controls?
Being exempt from 510 (K) premarket approval process means that the medical device is not required to obtain the PMA; however, there are what are called general controls, which any device has to comply with. These are some of them:
o The medical device should be fit for its intended use;
o It should be satisfactorily packaged and clearly labeled;
o It should carry its manufacturer’s name and registration, as well as the listing forms meant for devices with the FDA;
o It should be manufactured in accordance with the established requirements, expect in the case of a few Class I for which a few recordkeeping requirements or general files will suffice.

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Health Economics and Reimbursement: know about medical devices for various purposes


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With the aging population and ever increasing health awareness medical devices have become common home goods. Folks stricken by chronic sickness are watching and treating themselves reception for additional consistent management of conditions and up their approach of life. Medical Device Design for home use is correct, affordable and effective and promptly out there.

Many doctors are causation their patients home with the order of watching and recording their pressure level between visits for Health Economics and Reimbursement. These patients will affordably purchase associate automatic digital pressure level monitor and arm cuff over correct enough to produce knowledge back to their doctor. Several of the monitors have a recording feature and therefore the patient will merely bring their medical device with them to their follow up doctor appointment permitting the doctor to review their trends.

Additional advanced models will interface with home computers to transfer or export the info to a file for printing or emailing to their doctor. Most blood pressure monitors are battery steam-powered however several will use A/C power adapters to use 110v/220v wall plugs. There are multiple sized pressure level cuffs out there for several of the reputable whole devices and specialized medical specialty and thigh cuffs. These widespread home medical devices are often shipped to the patient’s door for below $ 40 with additional advanced units move to $ 100.

Chronic heart disease and COPD patients are finding worth in trailing their condition between doctor visits employing a pulse measuring instrument. These medical devices are little, battery operated monitors that live chemical element level within the blood. By mensuration the quantity of infra-red and red lightweight absorbed by hemoglobin the device will reckon chemical element level within the blood (SpO2%). Typically, the device is placed on the user’s tip and among ten to twenty seconds can offer chemical element level and pulse. Like the pressure level monitors, additional advanced models can record knowledge samples over time for later review. This is often fashionable sleep study patients and watching for sleep disorder. Because of the fashionable physical science business, basic however correct pulse oximeters are often uninheritable for below $ 30.

Monitoring a user’s condition is one factor. Treating reception makes a right away impact on the patient. Nebulizers are medical devices that flip liquid medication into a fine mist to be inhaled. The volatilized medication is meant for the airway and lungs to deliver medicines. For many, a nebulizer is often an additional soothing replacement for associate inhalator. They are electronic medical devices usually A/C steam-powered however there are battery operated travel versions out there creating the treatments additional convenient. So Medical device reimbursement is linked with treatments. These devices are often purchased for below $ 30 and provide nice worth for home treatment.

I am content publisher of We provides step by step guidance to getting medical device reimbursement, medical device design , 510K clearance, FDA clearance Process and FDA device approval.

Tiny origami-inspired devices are opening up new possibilities for minimally invasive surgery
Some of the BYU technology recently licensed to Intuitive Surgical, leader in robotic surgery

BYU mechanical engineering professors have made a name for themselves by applying the principles of origami to engineering. Now they’re applying their origami skills to a new realm: the human body. Mechanical engineering professors Spencer Magleby, Larry Howell, Brian Jensen and a team of students are working toward surgical technology that will allow for the manufacturing of instruments so small that the size of incisions necessary to accommodate the tools can heal on their own—without sutures.

“The whole concept is to make smaller and smaller incisions,” Howell said. “To that end, we’re creating devices that can be inserted into a tiny incision and then deployed inside the body to carry out a specific surgical function.”

As a part of their work, BYU just licensed a series of compliant mechanism technologies to Intuitive Surgical, the world leader in robotic surgery and the maker of the popular da Vinci Surgical System. The deal is the latest in a number of collaborations with Intuitive Surgical, which connected with BYU on advice from the White House Office of Science and Technology Policy.

The researchers say their work is inspired by a need for increasingly smaller surgical tools; the industry has reached the limit to where they can’t go any smaller with traditional designs. BYU’s team has engineered new design concepts that eliminate the need for pin joints and other parts, instead relying on the deflection inherent in origami to create motion.

“These small instruments will allow for a whole new range of surgeries to be performed—hopefully one day manipulating things as small as nerves,” Magleby said. “The origami-inspired ideas really help us to see how to make things smaller and smaller and to make them simpler and simpler.”

One such instrument is a robotically-controlled forceps so small it can pass through a hole about 3 millimeters in size—roughly the thickness of two pennies held together.

Outside their work with Intuitive Surgical, BYU’s team is developing concepts such as the D-Core, a device that starts out flat (to be inserted into an incision) then expands to become two rounded surfaces that roll on each other, mimicking the movement made by spinal discs.

Magleby says the work they are doing on medical devices is not much different in principle than the work they’ve done for NASA to create compact space equipment.

“Those who design spacecraft want their products to be small and compact because space is at a premium on a spacecraft, but once you get in space, they want those same products to be large, such as solar arrays or antennas,” Magleby said. “There’s a similar idea here: We’d like something to get quite small to go through the incision, but once it’s inside, we’d like it to get much larger.”

BYU’s latest research on origami-inspired engineering appears in the February issue of academic journal Mechanism and Machine Theory.

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How Medical Device Integration Can Improve Productivity


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Health care has been in the news for the last year, quite prominently, but most of the reporting has been about politics, new legislation and what are called macroeconomic effects of medical care in the U.S. However, for the doctors, nurses, IT personnel and, especially, Chief Information Officers (CIOs) that provide and manage the care and the facilities involved, other subjects are much more important. Even this far into the much-ballyhooed Third Millennium and the reigning Information Age, medical professionals are still seeking to close the digital divide separating essential medical devices from their electronic medical records.

When Massachusetts General Hospital (Mass General) designed the so-called Operating Room of the Future all the way back in 2002 (ages ago in technology time), they worked long and hard on ways to integrate all the information coming from the various devices in the OR. They noted that the lack of plug-and-play standards and the difficulty of achieving interoperability of the devices and multiple information flows were serious barriers to progress. Some progress has been made since then, especially in cardiology and radiology, but more needs to be done even there, in addition to the other operating environments needing point-of-care systems.

EMR evolution

From IT and clinical perspectives, the need to merge medical device data in to Electronic Medical Records (EMR) is critically important. The problem has been the lack of a standard for data exchange. There are scores of different device manufacturers with their own proprietary operating systems, and finding a cost-effective means of connecting everything was not a simple challenge. However, it was not a challenge that could be delayed or overlooked, as it went to the core of many health care problems, such as management overhead and problematic data access.

Without connectivity between EMR and device data, medical personnel resort to any number of inefficient and risky activities, like scrawling vital signs on paper and manually updating charts for patients. This not only delays the delivery of vital information (literally), there is a greater possibility of human error, with typos, misspellings or numbers being transposed or left out. This is the major weakness of manual-entry systems, and it is what is to be overcome by new means of medical device integration.

Standards on the way?

Mass General’s 2002 trial program led to the creation of the Medical Device Plug-and-Play Interoperability Program, which works to develop, implement and popularize industry-wide standards. The playing field is larger than any individual medical center, as patients move and EMR data needs to follow them wherever they go. If every hospital develops its own system, there will be internal connectivity, but little ability to interact and work with other medical centers. This speaks to the need for a simplified, easily instituted approach such as is available now from leading device integration firms.

There are also some EMR vendors that have addressed the connectivity issue from their side of the equation, but the problem of standardization is not solved in their approach. The future seems to be one where hospitals will begin by using third-party integrators, and then work through industry and trade groups to come to an agreement on data-exchange standards and other operational guidelines. Some vendors want to push their own so-called middleware solutions, but this is only a band-aid on the problem. The real solution lies in standards and the creation of intuitive software that can be learned by medical personnel in a short time.

Bottom line

Various software vendors are working to perfect what they call interface engines, which allow connection to hundreds of different devices. They automate the collection of data from bedside, OR and mobile vital signs monitors and translate that data into a standard format. Before the information is forwarded to the EMR system, doctors, nurses and/or other clinicians can review and approve it. This kind of automation is already quite popular with medical personnel, as is anything that speeds the transfer of life-saving data. Medical professionals want to treat patients, not struggle with technology. (That is what IT people are for.)

Clearly, productivity and patient outcomes will both improve when information is handled in a more efficient manner. Medical device integration, and the implementation of systems to feed the device data into the EMR system, is a major item on the national health care to-do list. It is arguably more important than political wrangling, which is why health care professionals are focusing so much energy and attention on it.

James Cauthin is a representative of iSirona. Implementing iSirona is faster and easier than any other solution on the market. There are no boxes on the wall, no hardware costs and no tangle of cables to connect. It’s software and it works regardless of department, device type or your current environment. For more information about Medical device connectivity, visit us online today!

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Shelhigh Medical Device Manufacturer-Under the Gun-FDA Claims of Repeated Problems


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Many of us remember the TV Shows The Six Million Dollar Man and The Bionic Woman, but most of us had no idea how close we would come to rebuilding our human bodies in the 21st century. Inventions and advances in medical technology have given so many a ‘second chance’ at life.

But, many times there may be a price to pay, as in the case of Shelhigh. Shelhigh is known for producing some of the best and most lauded medical devices available for the last ten years, but problems with repeated contamination at Shelhigh’s single facility in Union, NJ not only caused a recent FDA ‘recall’ but these continued contaminations during the manufacturing process have potentially put at risk those patients who have been implanted with Shelhigh devices.

Shelhigh’s violations include: manufacturing products in a facility with a poorly constructed and poorly maintained clean room where sterilized devices are further processed; failing to adequately monitor critical manufacturing environments for possible microbial contamination; failing to properly test products for sterility and fever-causing contaminants; and failing to scientifically support product expiration dates.

Shelhigh is well-known for its No-React tissue poducts which were developed for the express purpose of resisting infection. Unfortunately, even if the product was well-developed, the fact that it has been manufactured in a physical environment that itself was contaminated is not only counterproductive to Shelhigh, but dangerous to those who have trusted this company with their very lives.

Who is at risk? Because infection can best breed in those who are already compromised, critically ill patients, pediatric patients, and those with other diagnosed immuno-compromising illness’ are most at risk, because their bodies are unable to fight off the most innocuous infections.

Shelhigh’s medical devices include pediatric heart valves and conduits, which are tube-like devices used for blood flow; surgical patches; dural patches; nnuloplasty rings and arterial grafts.

The following is a list of Shelhigh products:

BioRingT (annuloplasty ring)
GoldT perforated patches
Internal Mammary Artery
No-React Dura Shield
No-React EnCuff Patch
No-React Pericardial Patch
No-React Pneumopledgets
No-React VascuPatch
No-React Stentless Valve Conduit
No-React Tissue Repair Patch/UroPatchT
Pericardial Patch
Pre Curved Aortic Patch (Open)
Pulmonic Valve Conduit No-React Treated
BioConduitT stentless valve
BioMitralT Tricuspid valve
Injectable Pulmonic Valve System
MitroFast Mitral Valve Repair System
NR2000 SemiStentedT aortic tricuspid valve

If you are a patient who may have received one of these devices:

1. Contact the surgeon who performed your surgery and have your records checked to see if one of the affected devices was, in fact, implanted.

2. If you already know that you have one of the affected devices, then contact your doctor promptly.

3. If your doctor gave you after-care instructions when you left the hospital, be sure to strictly adhere to those instructions.

4. Be certain to contact your surgeon or family doctor if any signs of infection are present. Signs include, but are not limited to:

a. Fever

b. Unusual pain, swelling, redness, and warmth in the area of your implant

c. Drainage or discharge from the incision used during the procedure to implant the device

As a patient, please understand that the seizure of Shelhigh medical devices only means that the existing devices at the company will not be introduced into the market until and when the FDA determines that sanitary conditions within the manufacturing plant have been remedied. While some types of contamination may affect the life of the medical device, it does not necessarily mean that your device will need to be removed. Seizure is meant to stop further distribution of a product until safety standards are met.

Finally, be certain to notify all of your doctors that you might have a Shelhigh implant that falls within the ‘recalled’ group.

As we see personal rights, individuals’ access to the courts and corporate accountability being eroded by ro-business and anti-consumer legislation and rule making by our present lawmakers, we are seeing corporate America becoming more and more brazen in dealing with federal agencies. Corporate America feels that they can get away with most things these days, that the federal regulatory agencies do not have much power and that those agencies certainly are not backed up by the White House. This feeling manifests itself in corporations like Shelhigh defying the FDA.

John Bisnar is a partner at Newport Beach Personal Injury Law Firm Bisnar Chase. The Bisnar Chase law firm has dedicated their practice to victims of serious injuries due to defective products, negligence and malpractice.

Visit the main website at or call 888-265-0161

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FDA Reporting For Safer Medical Products


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The Food and Drug Administration (FDA) is responsible for regulating the safety and proper labeling of foods, medicines, medical devices, veterinary drugs, animal feed, cosmetics, vaccines, and blood products. Listed below you will find some information on how the reporting system works and on what manufacturers and healthcare facilities are required to do.

1. The FDA requires any medical equipment manufacturer to report any complaints of malfunctions, serious injuries or deaths caused by a certain piece of equipment. These regulations are included in the Medical Device Report (MDR) released in 1984 and updated in 1996 and 1998.

2. The main purpose of MDR has been to provide an efficient mechanism through which both the FDA and medical manufacturers can monitor adverse effects related to medical devices. In this way, the FDA intends to more rapidly detect when a problem arises so as to promptly correct it, before more serious incidents occur.

3. Reports can be submitted not only by medical device manufacturers and distributors, but also by the users of the devices. Device user facilities include hospitals, ambulance providers, outpatient treatment facilities, rescue services, and nursing homes. Even patients and families of patient have the ability to send a report to the FDA, on their official website. Nonetheless, private medical practitioners are not considered to be device user facilities.

4. The format and the information contained in the report depend on whether it is being submitted by the device user and distributor or by the device manufacturer. Device users and distributors have to submit info about the patient, the type of event, relevant medical records, the manufacturer’s name and contact details.

5. Reports sent in by device manufacturers contain more detailed information about the device, methods through which the equipment was evaluated as well as any actions taken to correct the situation.

6. Foreign device manufacturers that operate within the United States are required to designate an agent in the country that will take on the responsibility of sending reports to the Administration. The agent, which first has to register with the FDA, will have to follow the same regulations as all medical device manufacturers in the US.

7. Certain individuals are exempt from the obligation to report to the FDA. These individuals include practitioners who manufacture or purchase devices for the treatment of their own patients alone, persons who manufacture devices only for their personal research or study, and dental and optical laboratories.

8. Additionally, the FDA can also choose to grant certain exemption from reporting, upon a written request or even at its own discretion. Apart from exemptions, the Administration also has the power to grant manufacturers alternative forms of reporting, to change the frequency of reporting or to change the requirements.

FDA reporting for safer medical products may be a little tricky to understand at first but it is important for healthcare facilities, medical device manufacturers and distributors to be aware of it. The information presented above represents the most important aspects involved in submitting a report to the FDA regarding the safety of a medical product.

To learn more, visit our website about FDA Reporting for Safer Medical Products today and bookmark it to share with others!

A Primer On Medical Device Connectivity


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Technology has had a huge impact on most industries, and this is particularly relevant in the healthcare field. As an example, many of the tasks involved with patient monitoring that used to be done manually can now be done by a machine, thus freeing up nursing staff for other more important tasks such as patient care. Most people are familiar with heart rate monitors, automatic blood pressure machines and ventilators. These are standard medical devices that are used extensively in hospitals. Even with the advances in technology, most often the medical results recorded by the medical devices still needed to be transferred manually. That is until medical device connectivity emerged onto the market.

Defining Medical Device Connectivity

Medical device connectivity is technology that bridges the gap between the medical devices that are recording the patient data and the electronic medical record. Traditionally, the data would be recorded manually by nursing staff. Often, due to limited staff resources, there would be a delay in transferring the data to the patient record. Medical device connectivity uploads the data and transfers it immediately-and with a greater level of accuracy-to patients’ charts. This means that the attending physician or nurse can have more up-to-date information for better clinical decision making.

Benefits Offered by Medical Device Connectivity

Any hospital that incorporates medical device connectivity will soon wonder how they ever managed to operate without it. It is a simple yet functional software solution that improves productivity and patient care efficiency. Because the data is not being manually transferred to patient records, there is less risk of errors occurring. So not only is the data more accurate, it is in the medical record without any of the usual delays. This means that the most up-to-date data is always available to help physicians make informed decisions regarding patient care. Recording patient data is also time-consuming. When this information can be recorded automatically, it frees up nursing staff to spend more time on other aspects of patient care.

What is Involved in Installing Medical Device Connectivity Solutions?

Perhaps one of the greatest benefits of medical device connectivity is that it is a software solution. No additional hardware is required, greatly reducing the total cost of ownership. The software works off the principle that it integrates with existing hardware and medical devices, regardless of manufacturer. Typically, the software takes up to four weeks to be fully installed and integrated with the hospital’s existing systems. The user interface is so simple that clinicians can be up-to-speed in no time at all.

What Makes a Good Medical Device Integration System?

There are four important things to consider when looking at medical device connectivity solutions. The first is compatibility. Find out if the system can integrate with your existing hardware and software. This can have a big impact on the overall costs, so it is an important consideration. The second is coverage. This refers to integration of all systems and various departments. Will the system record the data no matter where the patient is? The third consideration is that of accuracy. Can physicians rely on the data being recorded and make their patient treatment decisions with a high level of confidence? The final consideration is that of cost. This needs to be looked at from an overall purchase, installation and implementation perspective. A good system should offer you a strong return on investment.

James Cauthin is a representative of iSirona. Implementing iSirona is faster and easier than any other solution on the market. There are no boxes on the wall, no hardware costs and no tangle of cables to connect. It’s software and it works regardless of department, device type or your current environment. For more information about capsule technology, visit us online today!

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Medical Cannabis Growing Operation in Oakland, California
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Image by Rusty Blazenhoff
A rotating lazy susan device that turns the cannabis plants to optimize exposure to lights.

I had to wear sunglasses in this room.

photo by Rusty Blazenhoff…

Are you planning to manufacture or export medical products in china? Then it is perfect time to well verse with China medical Device Regulations thoroughly. Moreover, by completely being acquainted with the rules and regulations you can successively pursue your business over there. No wonder medical help is required for each and everyone so in this regard starting a medical platform is the best thought but you need to perform your every work skillfully by keeping some valuable facts in mind. Out of which some of the important facts that need immense consideration are as follows:-

* Stay Alert: – Always stay alert while starting this type of business in the country like china. Although it is quiet difficult to judge the authentic suppliers but still you need to be aware about this issues and keep yourself protected from red listed suppliers. As this type of suppliers, highly damage the profitability and productivity of your company including your reputation too.

* Consider The Quality Not Quantity: – Always try to prefer those suppliers that serve with fine quality not the immense quantity at low price. By electing, those suppliers will assuredly boost up your business but will not hike your image or reputation and for that, you need to act wisely by selecting qualitative suppliers.

* Plan Strategically: – Before starting any business it’s always advisable plan the things strategically. However, in this case also always plan the stuffs in such a manner so that you can inevitably spread your footprints for long term. Always act smart by regularly checking how effective the resources and materials are used. Alternatively, always try to track how people are accepting your products and in what ratio. By doing this you can undoubtedly reach to your destination of success within a short span of time.

* Measure the Work Rate: – In every business, it is mandatory to measure the profit or the fruitful result of your investments. Therefore, act smartly by measuring how is the work culture of you and your employees are satisfying the customers. Moreover, in this regard you can smoothly judge your every Return on Investments. And the most important fact that you need to keep in mind is always try to employ the suppliers in a long term basis as frequent change of suppliers can adversely affect your business.

Furthermore, it is your responsibility to remember that safety comes first. So just, perform everything by following the medical rules and regulations ensuring your products can successfully meet the regulatory as well as safety needs for everyone. If you are still swinging in the dilemma about do’s and don’ts of this business then just give a close look at the above-mentioned tips and tweaks deliberately flashing an extensive idea to assist you for your business.

To additional information on China Medical Device Regulations then visit us