Certificates / Documents
EN ISO 13485
MDSAP (medical Device Single Audit Program)
Zertifikat (gültig bis 2024-11-30) Zertifikat (gültig ab 2027-12-01)
MDR – Medical Device Regulation (EU) 2017/745
Notified Body Confirmation Letter (EU) 2023/607
MDD – Medical Device Directive 93/42/EWG
Conflict Minerals