Johner Institut
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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.
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.
Our PRRCs work seamlessly with your internal teams, optimizing the interfaces between QM, development, and other departments.
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.
Save time and resources with optimized processes and avoid unnecessary rework with precise initial setup.
Benefit from our experience in dealing with authorities and notified bodies. We coordinate vigilance cases and support you in your communication.
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.
In the role of the Person Responsible for Regulatory Compliance (PRRC), we will:
Contact us now to find out how we can optimally support you as PRRC.
Phone
+49 7531 94500 20
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