Question
Just had an article referred to me about ISO 14971 that we all should read. It was a written by an academic researcher in product safety risk management and discusses the merits of ISO 14971.https://onriskof.com/2016/10/03/medical-device-risk-iso-149...
Thank you for your time and congratulations on your involvement in Medical Devices. I am writing because I am considering a shift in career toward medical device manufacturing. My background is management of high-tech/computer manufacturing and test ...
I am interested in learning the best process for acquiring an ISO 13485 Certification. From the research I have, it seems like accredited 3rd parties are the best way to go. However, there does not seem to be much information about the process as a w...
I recently reviewed a sterilization validation protocol for a client and I thought some of you might be interested in the things that needed to be modified:1. Make sure you specify the revision of all standards referenced and make sure the version is...
Hi all,I was wondering what exactly a Qualified Person (QP) in the field of medical devices does and means? According to some sources which I am reading, it says “Manufacturers shall have available within their organization at least one qualified per...
Most likely something discussed in the past and hopefully answered easily. We have been completing our 21 CFR Part 820 compliance and are in really good shape for a contract manufacturer of medical devices. I have been receiving competing information...
This morning I was listening to my favorite daily podcast. The podcast guest made an extremely controversial statement. He said that he no longer agrees with one of the most popular entrepreneurship books called “Lean Start-up.” The book encourages s...
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...
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...
