We offer
Person responsible for regulatory compliance (PRRC)
Book now your Person Responsible for Regulatory Compliance (PRRC) and be assured that an expert takes care of your processes and products.
What we offer
best used for:
- Start-up's and established companies
- Micro- and small companies
- Restricted budget
- Few products and processes
- Bridging gap till hiring a PRRC
As a service, Avanti Europe will provide a dedicated expert in the role as your PRRC. The PRRC can be booked as part-time resource in full compliance with Article 15 of the EU MDR (2017/745) for micro- and small companies. The PRRC is not available for other companies, i.e. for companies with globally more than 50 full-time employees or more than 10 million Euros in global revenue from sales.
Our experts in the role of your PRRC comply with the qualification demands from the Medical Device Directive (MDR) 2017/745. The role of the PRRC will cover the aspects of:
- Conformity assessment of each manufactured device according to the quality management system
- Compile the technical documentation and the EU declaration of conformity incl. maintenance of these
- MDR-compliant post-market surveillance tasks are carried out
- Reporting obligations are taken care of and fulfilled
How it works
Required Information:
- Governing documents
- Process descriptions and SOPs
- Product documentation and specifications
- Change and CAPA log
- Marketing and Sales information
Our experts acting as PRRC under your quality management system (QMS) require access to documents and information in order to fulfill their tasks best. Digital access is here the best choice but thanks to our versatile approach, paper documents can be used as well.
An Avanti Europe expert acting as the PRRC needs access to at least the following documents:
- Governing SOPs and policies
- Product specific documents and process descriptions
- Any changes to processes and products
- Technical documentation
- Documents regarding the marketing of the products
- Sales figures to potentially update thresholds for reporting
The costs
Cost structure:
- Transparent costs
- Simple billing structure
- Scalable with small price steps
Costs are transparently fixed at the beginning of a term. A term can be individually set or prolonged with a minimum of 6 months in order to benefit from the tool set of a PRRC and its expertise.
Depending on the volume of documents and number of products, the PRRC can be booked starting at a very low work load percentage. Depending on demand, further development, expansion of the market or alike, the PRRC resource can be easily scaled to the demand.