We inspect your active medical devices for European and Global market approval and work with you hand in hand to quickly and easily create and execute an individual test plan.
- Notified body for medical devices and in vitro diagnostics (NB 0120 and 0598)
- Product Safety (IEC 60601-1)
- Electromagnetic Compatibility (IEC 60601-1-2)
- Environmental Simulation (IP/transport test/HASS/HALT)
- Biocompatibility (IEC 10993)
- Radio (R&TTE/FCC)
- RoHS (IEC 62321)
- Software (IEC 62304)
- Functional Safety (IEC 61508)
- Usability (IEC 62336)
- Expert certification (GIS)
The SGS Group thus offers comprehensive services regarding laboratory testing, certification and evaluation for compliance with the Medical Devices Directive. Our team of SGS-TÜV Functional Safety complements these services for active / electrical medical devices.
Our services as accredited body related to Functional Safety also include evaluations for:
- IEC 60601-1 3rd Edition
- Programmable electrical medical systems IEC 60601-1-4
- Software-Life Cycle according to IEC 62304
- IEC 61508
We also provide manufacturers of medical software applications (APPs) assistance with the CE Conformity Declaration in accordance with the Medical Device Directive 93/42/EEC (MDD), Annex VII:
Your benefits
- Competent service worldwide from a single source
- Direct contacts with extensive experience in the field of medical technology