Person Responsible for Regulatory Compliance (PRRC)

As required by MDR, every manufacturer placing a Medical Device on the EU market must have a person who is responsible for the regulatory compliance of their product(s). Our advisors may act as the PRRC for your company.

In smaller companies, or in companies where the Regulatory Affairs department has not yet been established with the right experiences, there may be a need for external support of a person responsible for regulatory compliance. SDS MedteQ consultants do have the experience enough to be responsible for this role in your company.

In order to hold this role, it is important that the consultant is well into details on your QMS and product technical documentation. Depending on the size of your company, we will need to agree on a minimum number of hours that the consultant shall spend on coaching and supporting your daily regulatory and quality work, in order to be up to date on the status of your compliance.

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