The interrelationship between EN ISO 14971:2019/A11:2021, Annex ZA, Annex ZB, and the General Safety and Performance Requirements of Regulation holds great significance for device manufacturers in the EU. Collaborating with regulatory experts and notified bodies can further aid manufacturers in traversing these requirements adeptly and achieving compliance with plan.
https://mavenprofserv.com/unravelling-the-relationship-between-en-iso-14971-2019/
#GeneralSafetyandPerformanceRequirements #GSPRRegulation #ISO14971
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