Quality Management Certificates

ISO 9001 (448 KB)

ISO 13485 (358 KB)

ISO 13485 MDSAP Certificate (441 KB)

ISO 14001 (269 KB)

ISO 14001 - Annex I - Certified Sites (791 KB)

ISO 50001 (270 KB)

ISO 50001 - Annex I - Certified Sites (518 KB)

MDR EU certificate G10 (Class IIa and Class IIb Devices) (296 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)