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