EN ISO 13485in-force
EN ISO 13485:2016 — Medical devices - Quality management systems - Requirements for regulatory purposes
EN ISO 13485:2016
Applies from 2011-01-01
Summary
EU MDR harmonised standard EN ISO 13485:2016: Medical devices - Quality management systems - Requirements for regulatory purposes.
Scope
MDR (Regulation (EU) 2017/745) harmonised standard — Medical devices - Quality management systems - Requirements for regulatory purposes.
Expert analysis
SaveOur compliance experts are preparing a detailed analysis for this regulation. Check back soon.
Want this analysis for your product?
Enter your product features once — ComplyMatrix maps all applicable EU regulations, obligations and testing requirements in minutes.