Article 15 MDR

For micro or small manufacturers, we have the authority to be able to provide a Person Responsible for Regulatory Compliance (PRRC) service as detailed in article 15 of the MDR (EU 2017/745). This person must ensure that regulatory activities are undertaken at all times. Our regulatory experts have vast experience in dealing with medical device testing requirements in line with the appropriate product safety standards. Get in touch with our team to discuss how we can help you with your medical device testing and the Medical Device Regulations.

For more information on Article 15 MDR talk to Cranage Veritas