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Tag Archives: quality system
Europe MDR General Safety & Performance Requirements vs. MDD Essential Requirements
The Annex I “Essential Requirements” of the European medical device directives have been supercharged and reincarnated
Quality System Process Risk Management (ISO 13485:2016)
ISO 13485:2016 has a broader view of risk management than in the past.
ISO 13485:2016 Quality System Process Risk Management
ISO 13485:2016 has a broader view of risk management than in the past. Risks are to be considered in terms of the impact on medical device safety and performance, and in terms of meeting regulatory requirements. For managing quality system process risks, rather than adding a “Risk” section to each Standard Operating Procedure (SOP) as some haveContinue reading “ISO 13485:2016 Quality System Process Risk Management”
Damn…we failed verification testing!
I can think of 3 options when engineering specification (design verification spec) is not met.
Notified Body Sleuthing
Unfortunately, there is currently no centralized database to search Notified Bodies and their Client companies. Here are some ideas for how to go about this.
FDA UDI FAQ Article
FDA UDI (DI+PI) FAQ, Sam Lazzara
Notified Body Selection Advice
Notified Bodies are no longer fighting for your attention – you need to fight for their attention!
FDA UDI Implementation in 12 Steps
Here is a high level task list intended for medical device labelers who want to implement FDA requirements for Unique Device Identification. Check out this blog page for general information related to UDI.
EO Batch Release Your Way to Full Validation
I have had several early-stage device company clients who are interested to get to “First In Man” (FIM) clinical use without breaking the bank. My job is to save the client enough money so they can pay my fee and have money left over for other things (like a great Christmas Party).
