QARA essentials (same as LinkedIn but with extras)
Really short post of (hopefully) useful information here on some extremely useful items that I and a few others I know use really frequently:
Adobe or some documentation tool that can
convert word to pdf, vice versa with strong search functionality.Enriched MDR / IVDR by Erik Vollebregt
ISO 13485 - A practical guide - https://lnkd.in/e8GQ_9Nf
Estonian Standards Agency for cheaper standards- https://www.evs.ee/en
MDCG Ongoing Documentation List - https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en
GHTF Process Validation Guidance - https://www.imdrf.org/sites/default/files/docs/ghtf/final/sg3/technical-docs/ghtf-sg3-n99-10-2004-qms-process-guidance-04010.pdf
Team NB Documentation List - This list goes way back to 2012 and before - https://www.team-nb.org/team-nb-documents/
Anyway, that’s it for this week!
Take care, Adam