Person Responsible for Regulatory Compliance (PRRC)

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Professional support as the Person Responsible for Regulatory Compliance (PRRC) for medical and IVD medical device manufacturers

Highest Level of Expertise

Benefit from our knowledge of all device classes and types. Our PRRCs are also experienced auditors and have first-hand knowledge of the expectations of the authorities and notified bodies.

Regulatory Safety

Avoid unnecessary device recalls and field safety corrective actions (FSCAs) through the competent review of your technical documen­tation and QM systems. We ensure that your devices are and remain compliant.

Smooth Integration

Our PRRCs work seamlessly with your internal teams, optimizing the interfaces between QM, development, and other departments. ​​​​​​​

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Audit Reliability

From now on, you can confidently face audits and inspections. Our PRRCs will prepare you optimally and provide you with professional support throughout the process.

Efficient Processes

Save time and resources with optimized processes and avoid unnecessary rework with precise initial setup.

Competent Communication

Benefit from our experience in dealing with authorities and notified bodies. We coordinate vigilance cases and support you in your communication.

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Protect yourself from a regula­tory perspec­tive with an experienced Person Responsible for Regulatory Compliance

As a manufacturer of medical and IVD medical devices or an autho­rized representative, you are subject to complex regula­tory require­ments.  

A lack of time, resources, or expertise can lead to costly delays, market access problems, or even warnings from the authorities. 

The consequences of a non-compliant QM system can be serious, ranging from revenue loss to reputation damage. 

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We take on the role of the PRRC according to MDR and IVDR and ensure your compliance

In the role of the Person Responsible for Regulatory Compliance (PRRC), we will:

  • ensure the review of the technical documen­tation according to your QM require­ments.
  • ensure that your technical documen­tation and declaration of conformity are up to date.
  • ensure the monitoring of post-market surveillance.
  • conduct internal audits with a PRRC focus.
  • support communi­cation with authorities and notified bodies.
  • coordinate vigilance cases and corres­ponding correction and prevention measures. 

Contact us now to find out how we can optimally support you as PRRC. 

 

Contact us, we're happy to help!
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