Regulatory Compliance

We have extensive experience in the design and implementing of Quality Systems that meet the requirements of ISO 9001, ISO 13485, 21CFR 820 & 21CFR 210, 211.

We provide expertise on the Risk Management Process for Medical Devices (ISO 14971) from both a Process, Use and Design perspective.

We provide expertise on the generation of Technical Files and Design Dossiers to meet the requirements of the Medical Device Directive (MDD).

We offer Regulatory Compliance expertise to start-up and existing Medical Device Companies engaged in the design and manufacture of medical devices.