GMED offers a wide range of services to support you through your certification process.
- Post Market Surveillance and Vigilance New Requirements under the European Medical Device Regulations
- The Clinical Evaluation Requirements (CER) under the EU MDR 2017/745
- Risk management applied to Medical Devices (ISO 14971:2019)
- Medical Device Single Audit Program (MDSAP) for Manufacturers
- ISO 13485:2016 Requirements
- European Medical Devices Regulation (EU) 2017/745
- Medical Device Electrical Safety – IEC 60601-1 3rd Edition (Ed3.1) and Introduction to Electromagnetic Compatibility (EMC) Requirements