Question
Kris Kelly
Software Quality Assurance & Testing * SDLC Process Improvement * Regulatory Guidance * System Performance Scaling
February 2018
I posted a common sense article about "Recurring" Medical Device Recalls last week - then today I read this article in the Star Tribune:Dozens of U.S. patients may have to undergo surgery to replace their Medtronic heart defibrillators following the ...
Most 510(k) submissions are Traditional 510(k) submissions. However, once you already have 510(k) clearance for your device, you still need to obtain FDA clearance for significant changes to the device. Approximately 10% of the submissions are Specia...
This short video is for anyone who touches operations: https://medgroup.biz/supplychain. "I see a lot of issues that never get resolved until they reach a breakpoint that senior executives must address," says Carlos Soares, the newest member of our M...
I need the group's help in recommending a few books that describe the FDA medical device regulation process as basic introductory to intermediate level of material. I have done an Amazon search, but I didn't find very convincing options.source: https...
What (exactly) does it take to orchestrate and command a successful launch of an entirely new medical device? Such as a device that can be categorized as the "next revolution" in a medical specialty and/or represents a disruptive technology. I am par...
What an awesome question. You only have 60 minutes to ask the FDA questions during a pre-submission meeting. Conventional wisdom is to spend 15 minutes with introductions, 30 minutes asking questions and finish with 15 minutes summarizing action item...
You wrote more than 10,000 words last week about euthanizing willing patients facing a terminal illness. Commenters were 75/25 in favor. Full conversation here. Selected PRO arguments: • Mia: If it's 'humane' to allow animals relief from suffering, w...
Hello my fellow colleagues. I had a question in regards to international Intellectual property filing. From a strategic stand point, would it be worth filing in China? Are patents enforceable over there? I filed in US, Europe 5 and Japan. Any thought...
Andrew Kyle
Medical Devices, Internet of Things, Agritech and Cannabis Speaker-Consultant
February 2018
A friend’s son was in an auto accident and had SC injury in C4, C5 and C6. Neurologist prognosis was permanent paralysis although he does have some feeling in his legs and limited wrist movement. Age is 38 male. He is in Denver. His father askes if I...
In October 2015 I recorded my first “Learning Lunch”, and the topic was “Getting the most out of pre-submission meetings.” One of the attendees asked, “Are pre-submission meetings mandatory for 510(k) submissions.” The answer was, and still is, no. H...
