Qualified Person (QP) - Responsible for Quality and Compliance
The Qualified Person (QP) is responsible for the release and quality assurance of medicinal products and certain medical devices in accordance with EU regulations (e.g. GMP, MDR).
As the central authority in the manufacturing process, the QP has regulatory responsibility for
- Batch release according to GMP requirements
- Review of production and test documentation
- Ensure compliance with legal requirements in accordance with EU regulations
- Quality Management and Supply Chain Audit
- Communication with Authorities and Notified Bodies
Our experienced experts can support you as an external QP or advise your company on the implementation and training of internal managers. Safety, quality and regulatory compliance are always our top priorities.
Rely on certified expertise. Ensure seamless compliance and product release.
Qualified Person (QP) - Responsible for Quality and Compliance
The Qualified Person (QP) is responsible for the release and quality assurance of medicinal products and certain medical devices in accordance with EU regulations (e.g. GMP, MDR).
As the central authority in the manufacturing process, the QP has regulatory responsibility for
- Batch release according to GMP requirements
- Review of production and test documentation
- Ensure compliance with legal requirements in accordance with EU regulations
- Quality Management and Supply Chain Audit
- Communication with Authorities and Notified Bodies
Our experienced experts can support you as an external QP or advise your company on the implementation and training of internal managers. Safety, quality and regulatory compliance are always our top priorities.
Rely on certified expertise. Ensure seamless compliance and product release.
Person Responsible for Regulatory Compliance (PRRC) - Safety & Compliance according to MDR
The EU Medical Device Regulation (MDR, Article 15) requires manufacturers and authorized representatives to appoint a person responsible for regulatory compliance (PRRC).
This is essential for complying with the MDR and includes the following:
- Monitoring the conformity of products according to the MDR
- Ensuring technical documentation and conformity assessment
- Regulatory review of market surveillance (PMS & Vigilance)
- Cooperation with notified bodies and authorities
As an external PRRC, we take on this responsibility for your company or train your employees to develop internal skills. With our expertise, you can ensure that your medical devices comply with the latest regulatory requirements – in a legally compliant, efficient and practice-oriented manner.
Ensure regulatory security with a qualified PRRC at your side.
Person Responsible for Regulatory Compliance (PRRC) - Safety & Compliance according to MDR
The EU Medical Device Regulation (MDR, Article 15) requires manufacturers and authorized representatives to appoint a person responsible for regulatory compliance (PRRC).
This is essential for complying with the MDR and includes the following:
- Monitoring the conformity of products according to the MDR
- Ensuring technical documentation and conformity assessment
- Regulatory review of market surveillance (PMS & Vigilance)
- Cooperation with notified bodies and authorities
As an external PRRC, we take on this responsibility for your company or train your employees to develop internal skills. With our expertise, you can ensure that your medical devices comply with the latest regulatory requirements – in a legally compliant, efficient and practice-oriented manner.
Ensure regulatory security with a qualified PRRC at your side.