The PRRC has the responsibility for regulatory compliance for devices on the market, in clinical trials and clinical performance studies. This is conducted by ensuring that the technical documentation and declaration of conformity is drawn up and kept up to date, fulfilling the obligations related to post market surveillance as well as reporting and investigating vigilance issues. It is also required that the PRRC controls the conformity of devices before they are released.
For micro and small size companies, QAdvis can act as PRRC on behalf of the manufacturer. We are a team of highly competent and experienced quality and regulatory professionals, one consultant will be assigned the role, but with requirements of being continuously available, the team is prepared to step in when needed and in cases of urgency.
QAdvis consultants all have vast experiences from working with technical documentation and quality management systems for medical devices and IVDs, and they all meet and exceeds the requirements on previous experience from working in the field. QAdvis also have an internal certification process for PRRC to ensure high quality and understanding for the role.
If you already have a PRRC identified within the organization, we can support you with defining the role as well as training and understanding of the full range of responsibilities.
QAdvis is a solution-oriented trusted service provider for the medical device and in vitro diagnostic device sector. To enable and maintain global market access, we can with high level of knowhow and expertise within quality management and regulatory affairs support your company to be in compliance with applicable regulations and requirements. QAdvis was founded in 2013 and is based in Sweden. We are certified according to ISO 13485:2016.
