PRRC

 

A PRRC is key to placing your device on the European market

Therefore, they could also choose to outsource the service, for example to our Qarad experts. 

The “person responsible for regulatory compliance” must take responsibility for the product compliance before the notified bodies and the competent authorities. To start a PRRC role for a new company, a review of the QMS and all technical documentation of the product is required in advance. 

In addition, the PRRC must be notified by the company of any announced audit, any QMS or product change, and any complaint, recall, or field safety. This person must be permanently and continuously available to them.

Why Qarad?

To ensure easy access to the European market, it is important to choose an experienced person responsible for regulatory compliance (with at least four years of professional experience in regulatory affairs or in quality management systems related to medical devices) who can guide you through the process.

Qarad's experts can act as your outsourced PRRC, helping your company comply with EU regulations for medical device and IVD manufacturers. 

With over 20 years of industry experience, we can guarantee you the benefit of an outsourced center of excellence for all quality & regulatory matters, in a cost-effective manner. 

Finally, the process for designating a Qarad PRRC is well structured and is based on the intensive involvement of the Qarad designated person for the PRRC service in the company’s processes.

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