Our PRRC Services Include
Regulatory Expertise
Our PRRCs have extensive experience and qualifications in regulatory affairs or quality management systems relating to medical devices. This expertise is essential in navigating the complex regulatory landscape of the EU.
Compliance Assurance
The PRRC is responsible for ensuring that your company is always up-to-date with the latest legislation and requirements referred to in the IVD and MDR. This includes maintaining equipment compliance, technical documentation, and fulfilling postmarket surveillance obligations.
Incident Reporting and Investigations
Our PRRCs oversee the reporting and notification of incidents and investigations, a critical aspect of regulatory compliance.
Communication Liaison
The PRRC acts as a vital communication link between your company, Notified Bodies, and Competent Authorities, ensuring that all regulatory communications are handled efficiently and effectively.
Audit Participation
The PRRC actively participates in internal and external audits, including subcontractor audits, bringing an additional layer of compliance assurance to these processes.
Independent Reviews
Our PRRCs can conduct independent reviews in various areas, such as GSPR listings, to ensure comprehensive compliance.
Flexibility for Small Enterprises
For micro and small enterprises, we offer the flexibility to outsource the PRRC role, providing continuous and permanent access to our specialized regulatory expertise.
Why Choose MDS Finland’s PRRC Services?
Comprehensive Regulatory Support
Our PRRCs provide complete support for all aspects of EU regulatory compliance, ensuring that your medical devices meet all necessary regulatory standards.
Specialized Knowledge
With a team of PRRCs who are well-versed in the nuances of the EU MDR and IVDR, we offer unparalleled expertise in the medical device regulatory field.
Adaptability
We tailor our PRRC services to fit the unique needs of your organization, whether you are a startup or a large enterprise.
Ensuring Regulatory Excellence
At MDS Finland, our commitment to regulatory excellence is unwavering. Our PRRC services are designed to navigate the complexities of the EU MDR and IVDR, ensuring that your medical devices are not only compliant but also contribute to the overarching goal of public health and safety.
