Question
Does anyone have first hand experience or recommendations for a 3rd party outsourced provider for turnkey management of medical device complaint handling and postmarket surveillance services?source: https://www.linkedin.com/groups/2070960/2070960-630...
My presentation at the MedTech Summit in Amsterdam on 19 June 2017 on the product liability regime under the MDR and IVDR, its nexus with the EU Product Liability Directive and its impact on other provisions in the MDR / IVDRNew legal obligations and...
There are 11 different types of software validation documents that the FDA requires. One of the documents is a rationale for the "Level of Concern." Level of Concern (LOC) is a term that the FDA uses to categorize the risk of software as a medical de...
There a huge increase lately by quality managers in the topic of adverse event reporting. This is partly because the new requirements in ISO 13485:2016, Clause 8.2.3 for reporting to regulatory authorities. In addition, the publication of the new Eur...
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...
