At ARC Regulatory, we have considerable experience in bringing non-active and active medical devices through regulatory approval. ARC Regulatory can guide and assist in developing the product requirements from multiple sources, user needs, market-specific regulatory requirements and international product standards.
We are subject matter experts in risk management in compliance with ISO 14971; Usability Engineering per IEC 62366 and compilation of regulatory submission to clear your medical device for sale in global markets.
Working knowledge of 60601-1 3rd edition requirements and other collateral standards, and liaising with your certification body through product testing.
Experience on a range of high complexity medical electrical equipment and systems, from dialysis, blood filtration, microwave and radiofrequency ablation to neuro-modulation technology.
Fully conversant with the requirements of the new EU Medical Device Regulation, and its impact on medical device manufacturers and other economic operators.