The RvA has published a new version of SAP-C021 concerning the certification according to EN ISO 13485 (medical devices). This protocol serves as a practical supplement to RvA Policy Rule BR002.
Specific Accreditation Protocol C021 contains a description for the accreditation of certification according to EN ISO 13485 (Medical devices).
Compared to version 2, dated 6 June 2017, the following significant changes have been made:
Click here for new version SAP-C021.