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Medical Devices | EU MDR

Impact of of MDCG 2021-24 on the Classification of Spinal Implants

The recently released guidance on classification of medical devices is very concerning for manufacturers with spinal implantable medical devices. MDCG 2021-24 appears to have classified many spinal fusion devices that were previously thought to be Class IIb as Class III. This means a more intense application process, closer scrutiny from notified bodies, and a significant resource investment into reclassification.
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Medical Devices | News | R&Q | EU MDR | R&Q Hires

Welcome, Jacob Foster: Regulatory and Quality Solutions' New Senior Principal Engineer

Jacob Foster brings 20+ years of medical device and pharmaceutical regulatory, quality, and project management experience to R&Q. He also brings an engaging personality, eager to do more for clients. Pittsburgh, PA -- Regulatory and Quality Solutions LLC (R&Q) exists to improve people’s lives and bring more safe and effective medical devices to market for medical device and combination product companies. Our results derive from a cohesive, hard-working, entrepreneurial, and supportive culture – a culture in which Jacob Foster effortlessly fits in. R&Q is truly ecstatic to announce that Jacob Foster has been named Senior Principal Engineer. An industry veteran of the global pharmaceutical and medical device industries, Foster brings extensive management, project leadership, and hands-on quality systems development experience to R&Q’s rapidly expanding operations team. His years of experience in the ever-changing regulatory environment  - including the upcoming and all-important EU MDR - strengthens R&Q's ability to expertly and efficiently serve clients. Foster has lived through uncertain times in the industry and despite the complexity of changes, has a track record of successfully navigating and deciphering them. “I met the team at R&Q about three years ago, and became “fast friends” with each and every team member I was introduced to," said Foster. "So when the opportunity arose to join R&Q, it was one of the easiest decisions I have ever had to make. The culture of R&Q and the earnest sincerity to contribute to patient safety and client success is tangible. Who would not want to be a part of that?”
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Medical Devices | quality systems | News | iso 13485 | R&Q | Minnesota

Minnesota Momentum: R&Q Hires Member of ISO Technical Committee 210, Mark Swanson

Mark Swanson is R&Q's new Director of Minneapolis–Saint Paul (MSP) Territory. Welcome, Mark! Mark's addition firmly establishes R&Q in the Twin Cities and prepares R&Q to handle growth in the region. The hiring also builds upon R&Q's existing technical leadership, increasing company-wide capability. Mark will certainly be seen and heard across Minnesota on behalf of R&Q, starting today at MD&M Minneapolis! Mark is a Senior Member of ASQ and holds ASQ certifications as a Certified Biomedical Auditor (CBA), Certified Quality Engineer (CQE) and Certified Manager of Quality/Organizational Excellence (CMQ/OE). Read on as we ask Mark three questions about his work on the ISO Technical Committee and shed light on his background/experience.
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Medical Devices | UDI | MD&M East | md&m | Conferences

4 Things R&Q Learned At MD&M East

What an action-packed three days MD&M East was this year! Our team is exhausted, but in the absolute best way possible. I'm not sure how anyone who attended the show could've escaped the exhaustion... as the exhibit floor was BIG. If you're reading this and attended, hopefullly you found the conference worthwhile. We certainly did. Here are four things we learned this year.
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Medical Devices | OSA | Clinical Studies | medicaldevice | Sleep apnea

This New Med Device Will Help You Sleep Better

Everyone appreciates a good night's sleep. A big obstacle to that is the fact that 18 million American adults suffer from Obstructive Sleep Apnea (OSA), and the condition arises simply from a wayward throat muscle. A new study by Dr. Richard Schwab, co-medical director of the Sleep Center at the University of Pennsylvania School of Medicine, shows how a new technique that can correct the issue.
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Medical Devices | CT Scanner | Creativity | New York

Revisiting a Classic: The Pirate-Themed CT Scanner

Behold medical device ingenuity at its finest. In 2013 the NewYork-Presbyterian Morgan Stanley Children's Hospital purchased a pirate-themed CT scanner, and the result is an incredible way to put children at ease before being scanned. See the rest of the creativity in pictures below.
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Medical Devices | News | FDA | R&Q

Announcing R&Q's Newest Senior FDA Compliance Principal: Former FDA Consumer Safety Officer Jake O'Donnell

R&Q is thrilled to announce the newest member of our team. Jake O'Donnell will act as Senior FDA Compliance Principal beginning February 2016. Jake formerly acted as Consumer Safety Officer (CSO) at the FDA for 20 years.
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Medical Devices | R&Q | Video

We Made a Video About R&Q! Here's Why.

One of R&Q's priorities in 2015 was to find new, distinctive ways to tell our story. We wanted to make it abundantly clear to potential clients and employees that R&Q is first and foremost about improving lives. We also wanted to clearly explain how we improve lives. The result of our brainstorming was to create a short video that takes the viewer through the journey of how R&Q helps our clients - from start to finish.
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Medical Devices | military

Devices for the Military

This past weekend I travelled to the Chicago-land area to attend my brother’s graduation from Northern Illinois University and commissioning into the US Army. He will be reporting to Fort Leonard Wood, Missouri for officer training as part of the Army Corps of Engineers. This has been a very proud and exciting time for all of us.
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Medical Devices | Artificial | Larynx | cancer | Clinical Studies

Deep Breaths

The standard treatment for patients with cancer of the larynx is to have a tracheostomy tube installed. Tracheostomy tubes are Class II devices, under 21 CFR 868.5800. According to ProTip CEO Maurice Beranger, this technology has not changed in 140 years. Tracheostomy tubes impair a patient’s ability to breathing through the upper airway and talk normally.
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Medical Devices | artificial knee | running | biomechanics

Pounding the Pavement

Earlier this year I joined a running club, Steel City Road Runners (come run with us!). I’m still a newbie, but I really enjoy the challenge that running provides. This past week, the Boston Marathon announced to applicants who would be awarded the last 5,000 spots in the 2014 Boston Marathon. It was really inspiring to see many of the people in my group be awarded these spots, I know how hard they have worked, and I’ve pounded the pavement with them more than once.
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Medical Devices | Reliability | Use Case | HALT | quality

Reliability – From Bike Racks to Medical Devices

Every once in a while, when I’m not running, I like to take my bike down to the river trails of downtown Pittsburgh. I throw my bike rack on my car, strap it in, and I’m ready to go. Being as I only used my bike rack about ten times since I got it, I was surprised when I went to secure the bike and the plastic strap was broken. The strap is not removable or replaceable, so for now I’ll have to stick to running. Luckily, I have my receipt and the manual that came with the bike rack – and it says there is a lifetime warranty. I wrote a short note to the company explaining my situation and am hoping to get a positive response.
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Medical Devices | medical device industry | FDA | K97-1 | Guidance Document | regulatory | 510(k)

FDA 510(k) Memorandum #K97-1 “Deciding When to Submit a 510(k) for a Change to an Existing Device

The FDA is looking for industry input for the revision of FDA 510(k) Memorandum #K97-1 “Deciding When to Submit a 510(k) for a Change to an Existing Device,” January 10, 1997. This is a critical go-to document for the average Regulatory Engineer, so I have been thinking about what I would change to make it more straight forward. While I can appreciate how difficult it is to make general rules that can apply to an infinite variety of products, there are sections of this document that could certainly be clarified.
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Biocompatibility | Medical Devices | premarket submissions | G95-1 | standard iso | ISO 10993-1 | FDA | draft guidance document | Guidance Document | biological evaluation | iso 10993 | fda clearance

New Biocompatibility Draft Guidance

FDA issued a new draft guidance document on biocompatibility on Tuesday April 23, entitled Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing. It is intended to replace the ODE General Program Memorandum #G95-1. G95-1 was issued in 1995 in the span of 18 years a lot has changed regarding FDA’s view on biocompatibility.
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harmonized symbols | Medical Devices | medical device labels | standards development organization | labeling | regulators | labeling products | FDA | medical device | labels | regulatory structure | biological product | sdo

Crash Those Symbols - FDA Proposed Rule

Make some noise people - the FDA may be making labeling easier on the medical device and biological product industries by way of harmonized symbols!
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mammogram | Medical Devices | mammograms | usability | medical device | breast cancer screening | human factors | regulatory | Women in Bio | quality | Breast Cancer

Human Factors

Recently I had to get my annual mammogram. They were running behind like doctor’s offices sometimes do - there were seven women in dressing gowns in the waiting room with me. After a few awkward moments, we all started to talk to each other. Every single one of the ladies talked about how they hate to come and get their annual mammograms. They talked about the pain of it, joked about the embarrassment of it - there was even a suggestion that they should serve wine in the waiting room instead of coffee. But each also showed a deep appreciation for the necessity of breast cancer screening - telling stories of aunts and mothers who were saved by it. Finally one woman told us that she was 39 when a mammogram detected her breast cancer for the first time. She was able to get minor surgery and was put on a regimen of annual mammograms. Six years after, she got breast cancer again. Again the mammogram was able to catch it early. She said she was now 57 years old and she felt like she owed 18 years of life to her doctor who suggested she get a mammogram at 39. There is no doubt about it; mammograms save people’s lives.
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trade | MDD | Medical Devices | trade deadline | trade-off | nhl | iso 14971 | risk management | 14971 | FDA | business risk | cmdr

Medical Device Development: Trades

As a somewhat rabid hockey fan there are a few days during the year that are considered sacred holidays: every playoff game, first day of free agency, and the trade deadline. My mind is on hockey because the trade deadline happens to be today. Outside of my insatiable desire to follow all hockey writers in the next 24 hours or so, I find myself thinking about trades in medical devices.
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Medical Devices | medical device development | March Madness | medical device industry | Innovation

March Madness

The season is upon us. Unfortunately, the season is not spring…winter still seems to be lingering. However, the season of March Madness is in full swing! Everyone’s bracket selections are in, and we wait to find out who is the National Champion.
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correction | Medical Devices | warning letter | fda inspection | immediate action | FDA | 483 | medical device | corrective action

RQS Feature Article - Successfully Addressing Warning Letters

Regulatory and Quality Solutions is featured in another publication this week! Our President, Maria Fagan, has written an article focused on the top five tips on how to successfully address FDA warning letters. The article is featured in MedCity News and can be found here. FDA warning letters are not to be taken lightly, and the careful handling of them is critical to ensuring your business can move foward to produce safe and effective product. The article provides five great bullet-points of advice on putting your company on the right track with the FDA
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Medical Devices | ergonomics society | medical device industry | human factors standards | human error | fda perspectives | industry guidance | regulatory submissions | usability engineering | CDRH | human factors group

HFES Health Care Symposium – What’s New in Human Factors and Usability?

Last week I had the opportunity to attend the Human Factors & Ergonomics Society Health Care Symposium. Since I work on medical devices, I mainly went to the presentations in the medical devices track and found them to be very interesting and educational. The opening keynote speaker, Dr. Ross Ungerleider, talked about practices that foster an environment (particularly in an operating room) conducive to innovative thinking and learning from human error. There were a number of presenters from the medical device industry who shared case studies, lessons learned, and various models for applying usability in their individual companies and departments. We were also fortunate to learn about some changes coming for human factors standards and the latest FDA perspectives on best practices, which I thought I’d share with you this week.
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language development | Medical Devices | cochlear implant | medical technology | cochlear implants | FDA | bionic eye | implant device

Make Sense

My son has a friend that was born deaf. When he was a small child, he had surgery to get cochlear implants. With the implants, he is able to hear. When his younger brother was also born deaf, his parents found that they carried a recessive gene that causes deafness. Both boys were able to receive the cochlear implants. They have developed normal language skills and are able to lead normal lives. Their only restriction is that they cannot play contact sports. I was talking to their mother, and I expressed my awe of medical technology - that deaf people can really hear when wearing the cochlear implant device. She told me that what surprised her most about the Deaf community was that most people who are deaf do not choose to get cochlear implants for their deaf children. There is a pride with being Deaf, and there is a whole close knit Deaf community. They do not see deafness as a handicap, but as uniqueness. Most deaf people are happy in their Deaf community so they want to share it with their children. They do not see deafness as something to be fixed so they usually do not elect to have the surgery. Adults would not benefit as much as children from the implants due to the critical periods for language development being passed. However, some adults have been thankful for the ability to experience hearing with the implants. Therefore, after much resistance, the Deaf community is slowly beginning to accept cochlear implants as a personal choice. I thought that was fascinating.
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standards | european commission | IEEE | MDD | Medical Devices | BSI | medical device field | medical device manufacturer | country code | FDA | ASTM | RTCA

Keeping Up With Regulations

In the medical device field the name of the game is Compliance. The reason for V&V testing is compliance. Prior to distribution you need to provide evidence of compliance. Everywhere you turn there are rules where the medical device manufacturer or distributor must provide evidence of compliance.
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Medical Devices | collaboration | medical device companies | partnership | regulatory science | regulatory pathway | nih | FDA | MDIC | medical device | Innovation | fda regulated products | medical device innovation | governing bodies | innovations

Regulatory Science

I heard an interesting new term today (new to me at least!) that I thought greatly impacts the line of work I am in. Regulatory science is "the science of developing new tools, standards and approaches to assess the safety, efficacy, quality and performance of FDA-regulated products". This involves not only developing devices and getting them approved by governing bodies but reducing the time and cost it takes to get the device to market.
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adverse events | Medical Devices | quality engineering | Regulatory Affairs | design quality | mhra | risk management | medical device | maude database | design dossier

Regulatory Thoughts

Up until the time when I joined the RQS team in November all I had ever truly worked on was Quality. Coming out of college I worked for a plastics bottling manufacturer in process development and quality control. My next job was design V&V closely followed by design quality engineering and risk management. My exposure to regulatory affairs was at an arms length. I was always the person on the other end of a conversation where I was the one being told that I need to do something in a particular way because the regulations said so.
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QMS | MDD | EU | Canada | Medical Devices | FDA | health canada | 21 cfr 820 | Preventive Action | iso 13485

A QMS Outcast: Preventive Action

We in the medical device industry throw the term CAPA around like it's a word that is common-place in our society (though, here in Pittsburgh, you'll get a lot of confused looks if you tell someone you've opened a CAPA as it is a local performing arts school. That's a strange nightmare with future Broadway stars re-enacting a root cause analysis!).
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Medical Devices | visual signal | risk level | alarm systems | safety feature | compliance

Auto Compliance

Coming to your commercial break at the 2014 Super Bowl at Met-Life Stadium - the automated compliance robot!
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Value Chain | Medical Devices | x-ray | healthcare | Insurance | customer

Who is your customer?

My mom works as an x-ray technician at a small orthopedic office in Chicago-land. Recently, the office ordered a new x-ray machine to replace their old and outdated equipment. My mom was very eager to use the new equipment, and was very happy to have an upgrade. However, after a few days of shuffling patients in and out of the room, she already had some complaints: the lever for the film was difficult to operate, there was not enough clearance between the machine and the door to get a stretcher in the room, the surface of the table was too slippery. One thing she said that really stuck with me was that no one ever asked her for her opinion when buying the equipment, even though she was going to be the one using it every day. She said she would have picked a different machine, if she had the choice.
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Medical Devices | Regulatory Affairs | medical device manufacturers | maude database

Medical Devices and Fantasy Football, More in Common Than You Think

I constantly find myself trying to draw parallels between my work life and personal life in almost everything I do and while I work in Quality and Regulatory for medical device manufacturers, I enjoy spending downtime playing fantasy football. Being that this weekend was the Championship round for the NFL I began some reflection. I found myself realizing that fantasy football has similarities to writing a technical file for a medical device.
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listing | MDD | EU | Medical Devices | us | gmp | mdufa III | FDA | FDASIA | enforcement actions | registration

Regulatory Intel - Jan. 21, 2013

Wrap-up of a few notable news stories from last week:
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Regions | Orthopedic Capital of the World | Medical Devices | biomedical | Pittsburgh | Catheter Valley | Ohio | Biomedical Industry

Location, Location, Location

January is usually that time of year where I start day dreaming about a vacation somewhere warm and sunny. California is always on the list. California has a lot more to offer than just its beautiful beaches and amazing sights. A recent article on the biomedical industry had some amazing statistics about California.
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Medical Devices | Holidays | Christmas | labeling | Intended Use | Stents | Risk | Hazards

Unwanted Gifts

Have you ever received a gift that you didn’t really want? Was it an ugly sweater from Great Aunt Margie, or a holiday pillow that didn’t quite match with your décor? People always say, it’s the thought that counts… but if that was the case, gift receipts would not be so important, and return lines at Kohl’s would not be so long the day after Christmas. A bad gift is not the end of the world; we just grin and bear it, and learn to craft a more detailed wish list the next year to avoid any room for ‘interpretation’.
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Medical Devices | NASA

Astronaut Icecream and Medical Devices

In recent years, my father has picked up a new hobby of star-gazing. What started out, as I believe, as an excuse to get out of the house and away from the mother-in-law, has slowly turned into a full-fledged astronomical geekfest (no pun intended). So, for Christmas this year, I thought it would be pretty awesome to buy the old man a star – a physical star in space. Yes, I know… no one can own a star, or a planet, or even Space itself, but the theory is amusing. Upon purchasing a star, its coordinates are issued, registered in the company’s database of stars, and the “owner” of the star is given the super-hero or super-villain ability to name it (now, I think a hilariously clichéd, yet appropriate name for my Dad’s star would be “Death Star”, but I am leaving the naming up to him).
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Biocompatibility | MDD | EU | Medical Devices | 10993-1 | FDA | health canada | medical device | Medical Device Directive | 10993

Biocompatibility - Simple, Right?

I’ve been working in regulatory for a company in which biocompatibility of device materials has been pretty straightforward and understood by all for many years. Annex A in ISO 10993-1 and FDA General Program Memorandum - #G95-1 is all you need. Check the chart for our device intended use and see that irritation testing, sensitization testing and cytotoxicity testing are required for any new device materials prior to introducing them into the market. Not only did our regulatory folks clearly understand these requirements, but our project teams were also onboard. If engineering wanted to change materials or change the material color or tint, they would contact a toxicologist to perform these three necessary tests. End of story.
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medical device innovation consortium | RAPS | off-label promotion | webinar | MDD | EU | mHealth | Medical Devices | mobile medical applications | Training | FDA | scanadu | Pharma | Medical Device Directive | mobile medical apps | US vs. Caronia | Caronia | United States vs. Caronia | qualcomm | x prize

Quick Hits - December 11, 2012

In a bit of a change for today's post, I'm going to highlight some of the big news items that came through my inbox last week:
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Medical Devices | News | FDA | marketing | off-label

United States v. Caronia

Yesterday, the United States Court of Appeals for the Second Circuit (based in NYC) made a 2-to-1 decision on United States v. Caronia (just one of many criminal cases pertaining to off-label use). This case even contained a supplemental briefing that had the litigants brief the applicability of Sorrell v. IMS Health Inc., 131 S. Ct. 2653 (2011), to the Caronia case. In Sorrell, the Supreme Court ruled that a Vermont statute, which regulated certain speaker and content-based restrictions related to pharmaceutical companies was in violation the First Amendment of the U.S. Constitution.
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Medical Devices | acronyms | Drugs | NDA | 510(k) | Combination Products | Pharmaceuticals

Exploding Bombs?

I have to admit, school doesn't teach you everything. During my first week at RQS, I was working with a client, and we were discussing labeling. She said I needed to get the bomb. Then, if I explode the bomb, everything will be good, and I'll have what I need. I left her office a little bit confused, and then it dawned on me that she did not want me to cause any sort of mass destruction...just to look at the BOM (Bill of Materials). Phew! It's just part of the jargon of the industry. Everyone uses abbreviations, numbers, code names, and pneumonic devices to mean any number of very important things.
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Steven Casey | Medical Devices | usability | technology | human error | human factors | phasers

Set Phasers on Stun

Several years ago a good friend who knows my interest in human factors and engineering psychology gave me a book called Set Phasers on Stun and Other True Tales of Design, Technology, and Human Error, by Steven Casey. I started to read it again recently and wanted to share it with you because the book demonstrates, according to the message on the jacket, “how technological failures result from the incompatibilities between the way things are designed and the way people actually perceive, think, and act. New technologies will succeed or fail based on our ability to minimize these incompatibilities between the characteristics of people and the characteristics of the things we think and use.” In the book Casey relates quite a few real-life stories about the interactions of people with modern technology and discusses the what caused the resulting human error. So if you need some new reading material, I encourage you to pick up a copy – I think you’ll find it fascinating!
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Medical Devices | Halloween | Courses | Training | Learning | FDA

Training and a couple jokes

Trick-or-treating in my neighborhood was moved to Saturday this year because of Hurricane Sandy...therefore I needed a few Halloween jokes to keep me going until this weekend. Here you go:
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mHealth | Medical Devices | mobile medical applications | Windows 8 | mma | medicaldevices | Android | medical device | mobile medical apps | medicaldevice | iOS

Mobile Medical Applications: Whale Cupcake

A good friend of mine in high-school was trying to understand the definition of a "hyperbole". Now, if Google would have been sophisticated enough at the time to include the "define:" feature, it would have returned the following for hyperbole: Exaggerated statements or claims not meant to be taken literally. Instead, I got the following nugget of awesome: So it would be like saying I ate a whale, when I really ate a cupcake? I think my response was laughter and "Sure, something like that..."
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Medical Devices | Stents | Innovation | PMA | de novo | Disruptive Technology

Blockbuster is no more - A discussion on disruptive technology

Every time I go home to visit my parents, one thing that comes up more often than not, is the fact that our local Blockbuster closed. It’s been about two years now, and they still can’t get over it. Me? I’m happy to rent from a RedBox, or even better, kick my feet back on the coffee table and click the OnDemand button. Video rental stores have been completely overtaken by something much simpler and cheaper. THAT is what a disruptive technology is.
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MDD | Medical Devices | Europe | CE Mark | Pittsburgh Technology Council

Devices Regulations in Europe

On Tuesday, I attended a Pittsburgh Technology Council event downtown titled “Medical Devices and the European Union: What does the Path of Entry Look Like?” which was sponsored by RQS! (We gave out stress balls in the shape of a pill!) I’ve posted a few times before regarding some of the regulatory hurdles of entering the US market, so I was very excited to get more perspective on the European path and share that information with all of you.
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Mission | Medical Devices | Substantial Equivalence | Innovation | Intellectual Property | 510(k)

Navigating Substantial Equivalence

Part of the mission of the CDRH is to ensure medical devices are safe and effective. Based on the risk of the device and the agency’s familiarity with the device type, different levels of evidence are required to convince the FDA that a device is safe and effective.
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occupational safety and health | osha guidelines | MDD | EU | Medical Devices | intuitive responses | design considerations | usability | interaction | occupational safety and health administration osha | environments | FDA | health canada | medical device | occupational safety and health administration | 510(k) | environmental conditions

Mobile Medical Applications: Mobile Medical Device Design

Many medical devices are meant to be used while in mobile situations. These devices could be wearable, carried in a user’s pocket or by hand, pushed like a cart, etc. Users of mobile medical devices expect them to be safe, reliable, durable, and easy to use while in motion or when transported, so let’s look at some design considerations specific to this subset of devices.
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Medical Devices | healthcare innovation | Mobile Health | medical claims | Health IT | Small Business | FDA | algorithm | HIMTA | mobile app regulation | FDASIA | mobile apps

Mobile Medical Applications: Innovation vs. Regulation

Mobile apps are absolutely exploding on the marketplace. It seems like so many business entrepreneurs are focusing on creating new apps that fit various needs such as games, music, organizational purposes and the list goes on. I recently read an article that discussed creating a Mobile Health office within the FDA. Specifically focusing on health alone, there are thousands of mobile apps that focus on counting calories, recording miles walked, and monitoring blood sugar levels.
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Medical Devices | Patents | Intellectual Property


Eureka! A light bulb goes off, and suddenly you’ve invented a great new medical device that will save millions of lives worldwide every year.
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smartphones | iphone 5 | iPhone | Medical Devices | google | application development | dual core | lumia | Mobile Health | mobile medical applications | nexus | health applications | FDA | windows millenium | technical specifications | app development | qualcomm

Mobile Medical Applications: Five or One Galaxies in the Lumia Nexus?

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iPhone | MDD | mHealth | Medical Devices | Mobile Health | mobile medical applications | mma | FDA | medical device | mobile medical apps | 510(k)

Mobile Medical Applications: Cyber Security

As with all software and technology, security is, and will always remain, a hot-button topic. It is even a point of contention for computer consumers - Mac vs. PC debates often will focus on how Mac's don't "need" virus protection (which is somewhat of a misnomer, but certainly good marketing).
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