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”
Tag Archives: medical devices
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).
Free Labeling
Much can be learned by reading “other Company” medical device labeling and promotional materials
Pyrogenicity – Dead Bugs?
I am not a microbiologist but I play one on TV!
Independence Matters
Independence is the basis for judicial systems and sporting matches. And for quality systems, it is generally accepted that personnel who are independent of an activity are more objective (impartial) than persons who are directly responsible for the success of the work.
