The Person Responsible for Regulatory Compliance (PRRC) has a vast range of responsibilities. This encompasses ensuring product conformity and product release, the preparation and updating of technical documentation and the EU Declaration of Conformity, post-market surveillance, and the monitoring of product safety, post-market surveillance, the reporting obligations regarding serious incident reporting and field safety corrective actions, as well as, verifying the issuance of a declaration in case of investigational devices.
High demands are also placed on the qualification of this person. A university education and at least 1 year of professional experience or at least 4 years of professional experience in regulatory affairs or in quality management systems relating to medical devices must be provided as proof of expertise. Start-ups, micro or small companies most often lack the means to occupy this function in-house, let alone have it permanently available.
Coming Soon: Kalms Consulting will offer start-ups, micro and small companies located within the EU to take over the tasks of PRRC for individual products as a third-party provider. Hand in hand with the manufacturer, Kalms Consulting tailors the processes around the PRRC and integrates them precisely into the customer’s quality management system, not to mention reviews existing QM processes and supports with the preparation of relevant documents. Paying special attention to existing structures in the company is part of our strength and invaluable when developing a suitable strategy for implementing the PRRC.