Our Services
PRRC REPRESENTATIVE
The world of medical devices is always growing and evolving, and we're not just talking about trends. With the constant influx of new regulations and international standardisation norms, the need for regulatory compliance increases, as does the need for regulatory support and representation by professionals with expertise and proven experience.
PRRC ACCREDITATION
Accreditation on regulatory compliance for medical devices in accordance with the MDR and IVDR, covering specific topics such as product registration, regulatory documentation or quality systems in order to prepare the PRRC to carry out the activity within the company in which they are working.
EC-REPRESENTATIVE
The EC-REP, or European Community Authorised Representative, acts as a crucial link between non-European medical device manufacturers and the European market. Established in the European Union, the EC-REP assumes legal responsibility for: Regulatory Compliance; Adverse Incident Management; and Post-Market Surveillance. In short, EC-REP acts as an essential representative for non-European manufacturers, ensuring that their medical devices meet the high quality and safety standards required in Europe.
COMMERCIAL REPRESENTATION
We carry out export promotion and management tasks for the products or services produced or distributed by your company. Given our knowledge and professional experience in the European market, this may be the best option for many companies.
Basic
In the Basic pack, the client will have access to 1 PRRC that will guarantee compliance with Art. 15 of the MDR/IVDR and Competent Authorities for the duration of the contract.
Standard
In the Standard pack, the client will have access to 2 PRRCs (1 Senior (holder) and 1 Junior (substitute)) who will guarantee compliance with Art. 15 of the MDR/IVDR and Competent Authorities for the duration of the contract. In addition, they will have access to audit support related to the product under contract.
Premium
In the Premium pack, the client will have access to 2 PRRCs (the 2 Senior PRRCs (1 holder and 1 substitute)) who will guarantee compliance with Art. 15 of the MDR/IVDR and Competent Authorities for the duration of the contract. In addition, they will have access to audit support related to the product under contract and support in responding to NCs.
