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Hello! I'd like to get some advice from industrial leaders on my inquiry. I am establishing complaint handling process reflecting ISO 13485:2016 requirement and FDA QSR, and one of new step is "Evaluation" for complaints which is many global companie...
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 ...
Last week I received this question specifically about 510(k) reviews, but I expanded the question to address both types of submissions.The most important thing is to be aware of the review process for submissions and understand the chain of command. ...
Did you know 77% of the cost to develop a 510(k) device is spent in clinical research and regulatory submissions? It's 80% for PMA devices. "A lot of that cost is due to how poorly we handle data," explained Jim Rogers, President of Nextrials, at the...
Does anyone have examples of investigations about medical device recalls that they could share that was something upper management actually LIKED? I swear this is about the most political aspect of the medical device industry I've found and I really ...
I am trying to figure out the best way to either do some bench tests or animal tests to obtain a CE mark/510K for my new nasogastric tube. Does anyone know the circumstances in which the FDA/CE would prefer some animal testing over bench data, or jus...
Earlier today I received the following question via LinkedIn: For verification and validation test records, are signatures needed?The person that asked the question thought the answer should be “Yes,” but is it required?This person read through the F...
The FDA actually reduced their fees this year, effective October 1, but the FDA offers fee reductions for small businesses too. Most of my clients qualify, but very few of these small businesses take advantage of the FDA fee reduction. Small business...
Hello, I'm wondering if there's a centralized publicly available list/ database of medical devices that have received the CE mark in Europe?Thanks for helping!Fiona
source: https://www.linkedin.com/groups/78665/78665-6181477980418695172
