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I am a big believer in having a centralized quality system glossary connected to the Quality Manual (Level 1). In doing so, Level 2 quality system procedures can simply refer to the glossary document for "Definitions" and need not repeat the definitions within the procedure - that is the entire point ...

Probably not regularly updated and not sure of its overall accuracy, but for casual hobbyists this WHO site is at least amusing. https://www.who.int/medical_devices/countries/en/ --------------------------------- Sam Lazzara Medical Device Quality Consultant San Francisco Bay Area, California ...

Thank you, all, for your feedback. If I make any updates to the flowchart I will post it in this thread. Rob, thanks for the input. My reasons for showing the "unadulterated" (EN) ISO 14971:2019 requirements versus the additional MDR requirements are: 1. Purely academic interest, trying to get ...

I took a stab at creating a single flowchart that points out differences between the 2019 standard and the MDR. This is just a starting point for me. If anyone has any input that I like/agree with (smile) I will surely update it. Here is a link to my flowchart. This link should work in the future ...