Question
I would like to check what is in your experience the best way to make sure that security patches installed by a hospital on your device are validated prior to installment? or in other words, what is the best way to ensure hospitals contact you when i...
I want to ensure we maintain conformance to 820.80 and also incorporate the risk-based approach to acceptance activities. We are looking for potential opportunities to reduce or eliminate inspections based on the item such as supplies vs raw material...
Three different clients of mine have recently received 510(k) deficiency letters from the FDA related to human factors. I have heard similar feedback from colleagues that specialize in FDA submissions. The FDA guidance document has not changed since ...
Hello, i'm working in spinal implant manufacturing company. DHF formalises input, output, verification, validation, review and transfer. After post production we continue to create revised DHF for design changes. Our DHF is system based e.g. Cervical...
Some companies ask physicians that helped them with product development review draft IFUs. However, these physicians are already familiar with your product, your company and they are highly skilled in the specific procedures your device will be used ...
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...
If you receive an NSE letter from the FDA, you have four options for correcting the problems and resubmitting your device to the FDA. However, you want to avoid receiving a second NSE letter for the same FDA.There are four causes for receiving an NSE...
If you ask “how much less documentation is required for the design of a Class 1 device compared with a Class 2 device?” you get a very different answer. Instead of 0% (Yes a DHF is required) of 100% (No DHF required), the answer is that you need 33% ...
Looking through the Final text of the EU MDR, it's obvious that although the familiar rules based classifications, risk based review and 3rd party conformity assessment remain, there's a whole lot of New and the bar is raised much higher. There are m...
Most regulatory experts work on medical device OR in vitro diagnostics--not both. Making the switch from one type of 510(k) to another is not that hard.First, the submission content and format requirements are the same. There are still 20 sections, a...
