In the medical device industry, the Person Responsible for Regulatory Compliance (PRRC) plays a pivotal role in ensuring that devices meet stringent regulatory standards before they reach the market. At PreCert, we offer comprehensive support and services to fulfill the PRRC role effectively, helping your company navigate the complexities of medical device regulations.

Why is PRRC Critical for Your Business?

Regulatory Assurance: The PRRC ensures that your medical devices are in full compliance with EU regulations, such as the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). This role is crucial for maintaining the legal and ethical standards required in the industry.

Quality Oversight:

As your PRRC, we oversee the entire lifecycle of your medical device, from design and manufacture to post-market surveillance, ensuring all processes meet the highest quality standards. This continuous oversight helps prevent compliance issues and enhances product safety and efficacy.

Strategic Compliance Management:

The PRRC acts as a central figure in your compliance strategy, liaising with internal teams and regulatory bodies to ensure that all regulatory obligations are met. This centralized approach improves communication, speeds up decision-making, and ensures that compliance is integrated into every aspect of your operation.

Our PRRC Services

1. Regulatory Strategy Development: We assist in developing a comprehensive regulatory strategy that aligns with your business goals and regulatory requirements, ensuring a smooth pathway to market approval and compliance.
2. Documentation and Record Keeping: Our experts manage all necessary documentation and records required under the MDR , ensuring they are current, clear, and compliant.
3. Training and Empowerment: We provide training for your staff to understand the regulatory requirements and the importance of compliance, fostering a culture of quality and regulatory adherence within your organization.
4. Ongoing Regulatory Support: Regulations are constantly evolving, and our ongoing support ensures that your organization remains compliant with the latest regulatory changes and industry best practices.