Basic info
Industry
medical equipment manufacturing
Sectors
90/385/EEC directive
Supplier & internal audits
PMA
CE marking
European Authorized Representative
Regulatory & Clinical Affairs
EN 62366 Usability
AIMD
IVDR
IVDR 2017/746
ISO 13485
ISO 14971
Training
93/42/EEC directive
MDR 2017/745
EN 62304 Software
Quality Management System
Medical Device
98/79/EEC directive
MDR
510k
Date founded
2001