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Person Responsible for Regulatory Compliance (PRRC)
Our regulatory experts provide PRRC support, helping you ensure product oversight, maintain compliance, and stay confident in a highly regulated market.
PRRC services
According to the MDR and IVDR, medical device manufacturers must have an assigned and dedicated Person Responsible for Regulatory Compliance (PRRC). The PRRC has the responsibility for regulatory compliance for devices on the market, as well as in clinical investigations and clinical performance studies. This is conducted by ensuring that the technical documentation and Declaration of Conformity is drawn up and kept up to date, and that the obligations related to post market surveillance as well as reporting and investigating vigilance issues are fulfilled. It is also required that the PRRC controls the conformity of devices before they are released. The PRRC must fulfill the strict competence requirements stipulated in the MDR and IVDR.
All manufacturers, irrespective of classification, must have this person continuously available to fulfill the requirements for placing devices on the market under MDR and IVDR. Our experts can help you understand the requirements for your company, as well as take the role as PRRC in micro and small companies. We can support you with defining the role, as well as training and understanding of the full range of PRRC responsibilities.
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Explore our quality and regulatory services
Regulatory strategy
We help you develop an efficient regulatory strategy to meet applicable regulations, mitigate risks, and accelerate time-to-market for your medical device.
Market registrations
Let our team of experts support market registrations of your medical devices in the EU, US and other markets.
Digital health and cybersecurity
Dedicated regulatory and quality experts to help you streamline your medical software development and ensure that you adhere to local and global regulations.
Technical documentation
Expert support in planning, preparing and updating your technical documentation to help you ensure compliance with applicable regulations.
Clinical evaluation
Proven expertise in planning and conducting a thorough clinical evaluation that supports the regulatory approval of your medical device.
Performance evaluation
Dedicated experts in planning and conducting a thorough performance evaluation that supports the regulatory approval of your IVD medical device.
Biological evaluation
We support you in planning and conducting a thorough biological evaluation of your medical device that is compliant with ISO 10993-1.
Risk management
Medical device risk management services for setting up and maintaining your risk management process and helping you prepare your documentation.
Usability engineering
Support for your usability engineering activities, from creating a process to preparing a usability engineering file for your medical device.
Due diligence
Quality and regulatory experts ready to support your due diligence projects with comprehensive appraisals of medical device businesses.
Person Responsible for Regulatory Compliance (PRRC)
Our experts can support you in understanding the full range of PRRC responsibilities.
Quality management system services
QMS services for medical device manufacturers to help you design, implement and manage your QMS to support your organization's needs.
US FDA QMSR
Expert guidance on the US FDA's QMSR and other US regulatory requirements to help medical device manufacturers successfully enter the US market.
Auditing services
Improve your quality management system with our internal auditing services for medical device manufacturers.
Post market surveillance
Post market surveillance services to help you systematically gather and analyze data on the quality, performance, and safety of your medical device.
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