Quality Management Certificates

ISO 9001 (419 KB)

ISO 13485 (353 KB)

ISO 13485 MDSAP Certificate (478 KB)

ISO 14001 (272 KB)

ISO 14001 - Annex I - Certified Sites (246 KB)

ISO 50001 (282 KB)

ISO 50001 - Annex I - Certified Sites (111 KB)

MDR EU certificate G10 (Class IIa and Class IIb Devices) (295 KB)

MDR EU certificate G11 (Class Is Devices) (295 KB)

MDR EU certificate G12 (Implantable Class IIb Devices) (295 KB)

MDD Annex II excluding (4) (335 KB)

MDD Annex II.4 (1.11 MB)

MDD Annex V (311 KB)