Person Responsible for Regulatory Compliance (PRRC)
Professional support as the Person Responsible for Regulatory Compliance (PRRC) for (IVD) medical device manufacturers
Highest Level of Expertise
Benefit from our in-depth 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 Certainty
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.
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 with Authorities
Benefit from our experience in dealing with authorities and notified bodies. We coordinate vigilance cases and support you in your communication.
Protect yourself from a regulatory perspective with an experienced Person Responsible for Regulatory Compliance (PRRC)
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.
We take on the role of the Person Responsible for Regulatory Compliance (PRRC) according to MDR and IVDR and ensure your compliance
In the role of the Person Responsible for Regulatory Compliance or 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.
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