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RQM+ Medical Device and In Vitro Diagnostic Blog
Topic: medical device industry
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FDA 510(k) Memorandum #K97-1 “Deciding When to Submit a 510(k) for a Change to an Existing Device
on 29 May 2013 | By Ryan Kasun
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...
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Hpfb | Medical Device Companies | Wikipedia | Money | Tga | Regulatory Risk | Medical Device Industry | Investors | Fda | Medical Device | Anvisa | Engineering Projects | Open Source Projects | Crowd Source
Crowd Source in Medical Devices?
on 17 April 2013 | By Ryan Kasun
Collaborative development, or for the purposes of this post we'll call it "crowd sourcing", seems to be discussed and used more frequently in the current business environment. Obviously, crowd sourced projects have been around for a long while (Wikipedia is just one well-known...
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March Madness
on 26 March 2013 | By Ryan Kasun
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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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?
on 20 March 2013 | By Ryan Kasun
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...
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Quality Agreement | 21 Cfr | Supplier Selection | Medical Device Industry | Fda | Supplier Management | Supplier Quality
Getting Control of Supplier Controls
on 20 March 2013 | By Ryan Kasun
It seems that for one reason or another supplier controls are a requirement that slips through the cracks of even some of the largest medical device organizations. Those of us in the medical device field should know better since 21 CFR Part 820 clearly includes requirements that...
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Alternative Materials | 21 Cfr | Leachables | Human Exposure | Dehp | Natural Rubber Latex | Latex | Medical Device Industry | Exposure Levels | Allergy | Materials | Bpa | Phthalate | Polyvinyl Chloride Pvc | Ethylene Vinyl Acetate | Phthalates
Latex and DEHP and BPA, Oh my!
on 15 March 2013 | By Ryan Kasun
They’re just as frightening as Lions and Tigers and Bears, but how much do you know about them? Are they in your medical devices?
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Da Vinci | Medical Device Industry | Technology | Medical Device | Technology Advancements | Surgery System | Robot-assisted | Intuitive
Technology Overkill?
on 22 February 2013 | By Ryan Kasun
Over the past few years, there have been some really great technologies that have changed the way we live our lives. Smartphones are the easiest example. Life would be a lot different if I didn’t have instant access to my e-mail, the weather, the spinning schedule at my gym, or...
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New Medical Devices | Medical Device Industry | Medical Device | Regulation | Sensors | Innovations | Medical Breakthroughs
New Medical Devices Coming Soon to a Hospital Near You
on 18 February 2013 | By Ryan Kasun
Recently I came across a FoxNews article (‘Medical breakthroughs on the horizon for 2013’ by Dr. David Samadi) that got me excited. The reason why I pursued the medical device industry was to be in a field that impacted people; a field that matters. I don’t care who you are –...
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Medical Device Industry | Taxes | Fda | Medical Device | Public Health | Govenment | Regulatory | 510(K) | Cdrh
Headaches
on 7 February 2013 | By Ryan Kasun
The FDA received funding to increase its workforce at the CDRH for 2012 and 2013. They have set aggressive goals to improve the turnaround times for 510K approval. They have instituted programs to retain their employees and to increase the reviewer to manager ratio. My...
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Ecopy | Federal Register | Rta | Proposed Rules | Mdufa Iii | Food And Drug Administration Safety And Innovation | Medical Device Excise Tax | Medical Device Industry | Mdufa | Medical Device Establishment Registration And List | Comparative Effectiveness Research | 2013 | Cer | Public Comments | Fdasia | Ecopy Program For Medical Device Submissions | Petition
New Year, New Resolutions
on 3 January 2013 | By Ryan Kasun
Happy New Year - I hope that all of our blog readers had a wonderful holiday and brought in 2013 with warm and welcoming arms!
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Nano Technology | Frontiers In Optics | Spider Silk | Optics | Nano | Medical Device Industry | Omenetto | Osa | Biomedical | Fio | Huby | Microchip | Optical Society | Implantables | Spider-man
Spider silk isn't just for Spider-Man
on 17 October 2012 | By Ryan Kasun
The vast majority of us are familiar with Stan Lee and Steve Ditko’s Marvel comic book series, "The Amazing Spider-Man", where he would go web-slinging from here to there, in order to catch the baddies (of course, there is a lot more to this story than just that… but...
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Nanomaterials | Medical Device Industry | Medical Device | Nanotechnology | Fdasia | Med-tech Industry
Nano-what? Nanotechnology.
on 5 September 2012 | By Ryan Kasun
Over the past 50 years, the advancement of technology has been beyond incredible. Although, we are not zipping around in flying cars, fearing the dreaded encounter with a hoverboard gang, or living amongst cyborgs, we are witnessing things never before thought possible. Such...
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