Person Responsible for Regulatory Compliance

According to Article 15 of the MDR, the manufacturer of medical devices is required to have, within its organization (or an external person for small companies), a person who is responsible for regulatory compliance and with the explicit responsibility to ensure that all 'Manufacturer's Obligations' are met (Article 10). Our team includes competent and experienced people to play the role of Person Responsible for Regulatory Compliance, ensuring:

• The verification of the conformity of medical devices according to the QMS (Article 10(9), MDR);

• Maintenance and updating of technical documentation (Article 10(4) and (6), MDR);

• Compliance with market surveillance obligations (Article 10(10), MDR);

• Fulfilling incident reporting obligations (Article 10(13), MDR).