Person Responsible for Regulatory Compliance (PRRC)

At MDS Finland, our specialists can fulfill the vital role of the Person Responsible for Regulatory Compliance (PRRC) for your organization, as mandated by the EU MDR and IVDR. The PRRC essentially serves as a management representative for regulatory compliance, ensuring your company meets all required obligations. Our PRRC experts are part of our core team and can be made available to your organization on an outsourced basis, seamlessly complementing your in-house resources as needed.

OUR PRRC SERVICES INCLUDE

Regulatory Expertise

Our PRRC professionals have extensive experience and qualifications in regulatory affairs and quality management systems related to medical devices. This expertise is essential for navigating the complex regulatory landscape of the EU.

Compliance Assurance

The PRRC is responsible for keeping your company up-to-date with the latest legislation and requirements under the MDR and IVDR. This includes maintaining device compliance, managing technical documentation, and fulfilling all post-market surveillance obligations.

Incident Reporting and Investigations

Our PRRCs oversee the reporting and investigation of incidents, a critical aspect of maintaining compliance and ensuring patient safety.

Communication Liaison

The PRRC acts as a key communication link between your company, Notified Bodies, and Competent Authorities, ensuring that all regulatory correspondence is handled efficiently and effectively.

Audit Participation

The PRRC actively participates in internal audits and supports external audits (including subcontractor audits), adding an extra layer of assurance during compliance checks.

Independent Reviews

Our PRRCs can conduct independent reviews in areas such as General Safety and Performance Requirements

Flexibility for Small Enterprises

For micro and small enterprises, we offer the option to outsource the PRRC role. This provides continuous, on-demand access to specialized regulatory expertise without the need for a full-time in-house hire.

WHY CHOOSE MDS FINLAND’S PRRC SERVICES?

Comprehensive Regulatory Support

Our PRRC experts provide end-to-end support for all aspects of EU regulatory compliance, ensuring that your medical devices meet every necessary standard and requirement.

Specialized Knowledge

With a team of PRRCs well-versed in the nuances of the EU MDR and IVDR, we offer unparalleled expertise in medical device regulations.

Adaptability

We tailor our PRRC services to the unique needs of your organization, whether you are a startup or a large enterprise, to ensure you have the support you need.

ENSURING REGULATORY EXCELLENCE

At MDS Finland, our commitment to regulatory excellence is unwavering. Our PRRC services help you navigate the complexities of the MDR and IVDR, ensuring that your medical devices remain compliant while contributing to the overarching goal of public health and safety.