Question
Danny Kroo
ISO 13485 medical device, AS9100, AS9120 aerospace and ISO 9001 QMS consultant & lead assessor QA/RA Manager at Montmed
December 2018
Hello everyone, what are the requirements for selling first aid kits in USA?The first aid kits will include medical gloves, BZK swabs and alcohol prep pads and the suppliers of each will be FDA approved for these products.What needs to be done to get...
Simply a gift for you today. If you have anything to do with medical device quality systems, click here for FDA slides for immediate download. Four slides that stood out to me It was hard to narrow down the four hours from four presentations to four ...
Does a medical device manufacturer have to re-label research only products (animal research only, not for use in humans) as investigational use (per 21 CFR 812) for use in IRB or IDE?The devices are not cleared and some may or may not be on a path to...
Netflix - The Bleeding EdgeBBC One Panorama - The Great Implant ScandalICIJ - The Implant Files Are these going to help or hurt the medical device industry? Are they adding fuel to the fire by rehashing known issues or helping advance patient safety ...
Robyn Barnes
Business & Real Estate Writer, Regulated Industry Business Development, GxP Lifeline Media Professional
November 2018
This really makes me nervous. Can people be trusted to only use this for good? And we won’t know for years what the side effects of the surgery will be.
I am reading the MDR again and am trying to get deeper knowledge. If an organization is transitioning to MDR and has class IIa/b devices on the market, how might they get around the requirement of clinical studies or equivalence?
I know a guy who got a $500,000 grant to make FDA data easier to search. As it neared completion, it was scuttled by two employees whose jobs would be jeopardized. Infuriating. So the answer to "which is the most frustrating FDA database" is probably...
José M. Montero
Technical Translations by Experts🔹Expert in Engineering🔹Expert in Medical Devices🔹Book a FREE consulting service⬇️
November 2018
Dear group-fellows, could you help Mediwords to get a better understanding of current MDR2017/745 awareness status so far in the industry? It won't take you more than one minute and no single personal data is collected, unless you willingly provide i...
If you make the selection just on cost, in about a year, you may be very sorry about the decision you made, began Mark Rutkiewicz, VP, Quality at Innovize. His was a really solid talk. I'll share the first of his five questions here. You can find the...
MDMA, the Medical Device Manufacturers Association, created this easy-to-join outreach to contact your member of Congress to include repeal of the medical device tax in ANY legislative packages enacted by Congress this year.Editor's note: Hey, it's J...
