Question
The most common way to answer this question is with a question.How long is a review supposed to take? orHow long does a review actually take?Most people want to know the answer to the second question, and they want real data to back it up. Therefore,...
Our product received CE certification. In addition to the product labels and IFU, We would like to indicate in our product' catalogue the CE Marking with N.B number. Is it allowed? Please explain/Make citation.Thank you.source: https://www.linkedin.c...
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...
Don’t ever believe what you hear. Instead, look it up. I think the software requirements are minimal in the newly released ISO 13485:2016 standard, but other experts disagree. In the QSR, software is also covered, and regulatory requirements are incl...
This particular question seems to be a common nonconformity during audits. There are three reasons for this:the question is on several regulatory checklists for certification bodies,training on regulatory requirements is seldom provided to design eng...
As per process validation definition in ISO-13485 and FDA CFR 21 Part 820 I have a concern where help from groups members is really appreciated,Recently I read a procedure that states that, since regular lots size are too big, sampling can be conduct...
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 ...
Like many of you, I have been slogging through the Practical Guide to ISO 13485:2016 since it came out end of September. To be honest I found it anything but practical. The guidance is a behemoth at 214 pages, contains circular references with vague ...
I'm now dealing with 510k, but can not understand from FDA website...From the "Deciding When to Submit a 510(k) for a Change to an Existing Device" in FDA website, it states "documentation" as document your analysis and file it for future reference. ...
It has now been some time since the release of the updates ISO 9001 and ISO 13485. There was some discussion in this group about how many medical device manufacturers maintain both ISO 9001:2008 and ISO 13485:2003 certification.It would be really goo...