ISO 13485 medical device, AS9100, AS9120 aerospace and ISO 9001 QMS consultant & lead assessor QA/RA Manager at Montmed
A company is interested in getting a private label agreement with an OEM to sell a Class II medical device in the USA. The OEM has 510(k) clearance and the only product change will be the company's name on the label. There will be no change for the i...
Analyst and scientist for biotech investment
Hi all, I am looking for a simple protocol to file a 510k exempt device to FDA, since FDA provides so much detailed information of 510k and PMA on the website. I will be grateful if someone could share some simple tips of what I should do for the 510...
Wound Dressing Manufacturers – FDA will be reclassifying your devices. Speak now before October 20, 2016 or forever hold your peace (at least until the proposed rule making)If your company manufacturers wound dressings containing drugs under the FRO ...
Regulatory Affairs for Medical Devices
Hello all,Do you know if the FDA can inspect your emails if you used email as a record as a proof of compliance?Thankssource: https://www.linkedin.com/groups/2070960/2070960-6326393967122489345
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 ...
Emilia Ana Gonzalez
Senior Regulatory Affairs Specialist at MIM Software Inc.
Hello! Looking for some input on the idea of a "catch up" 510k. If you have made many minor changes over time, and need to catch up- how is this done? How is it viewed by fda?
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...
Hello my esteemed colleagues!! I am attempting to learn as much as possible about the United States regulations and codes specifically regarding Medical Devices. I have a full list of predicate devices that I can prove do similar things to our device...
Quality and regulatory through innovative solutions
I'm new to my orthopedic implants and associated instrument company and inherited a 510(k) in review. In this 510(k) and those cleared in the last year, we had no discussion on usability 62366-1. We also didn't discuss evidence for biocompatibility b...
Advocate-Counsel at Bombay High Court - India
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...