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RQM+ Medical Device and In Vitro Diagnostic Blog
Topic: Innovation
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Investors | Patent | Patent Application | First To File | Medical Device | Patent Office | Law | Innovation | First To Invent | Us Patent Law | Patent System
Patent Law Changes
on 11 April 2013 | By Ryan Kasun
For over 200 years, the US has operated under a “first to invent” rule. This means that if two innovators independently submit a patent for the same exact invention, the person who can prove that they invented it first is the one who is awarded the patent.
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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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Best Practices | Quality System | Autonomy | Guidance Document | Innovation | Regulatory | Improvements | Quality
Autonomy with Boundaries
on 4 March 2013 | By Ryan Kasun
I have a teenager that just passed his Driver’s Test. As he pulls out of our driveway, I see the freedom, the possibilities, the trouble that he could get into. Although a bit poetic and a bit melancholy, it’s also a bit exciting. His father and I cautiously trust him – he’s a...
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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
on 26 February 2013 | By Ryan Kasun
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...
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Rethinking Innovation
on 12 November 2012 | By Ryan Kasun
One of my favorite topics about the medical device industry and technology in general is innovation. Rebecca's post last week discussed the Medical Innovation Summit - "Innovative to the Bone" hosted by the Cleveland Clinic. Although I was unable to attend the event, I did find...
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Blockbuster is no more - A discussion on disruptive technology
on 19 October 2012 | By Ryan Kasun
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...
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Navigating Substantial Equivalence
on 5 October 2012 | By Ryan Kasun
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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