PRRC Person Responsible for Regulatory Compliance
Why Outsourcing the Role of Person Responsible for Regulatory Compliance (PRRC) is a Smart Move for Medical Device Companies?
Medical device companies are facing increasing pressure to comply with a complex and ever-changing regulatory landscape. Keeping up with the latest regulations and standards can be a daunting task, especially for small and medium-sized companies that may not have the resources to build and maintain an in-house regulatory compliance team. That's where outsourcing the role of Person Responsible for Regulatory Compliance (PRRC) comes in.
PRRC is a critical role within a medical device company, as it is responsible for ensuring that the company is compliant with all relevant regulations and standards. This includes, but is not limited to, monitoring and reporting adverse events, maintaining the technical file and compliance with the EU MDR, FDA 21 CFR Part 820 and ISO 13485 standards.
Section 3, Chapter 1, Article 15 of the EU MDR cites the following as the responsibilities of PRRC:
- Check the conformity of devices with QMS procedures before they are released
- Make sure all Technical Documentation and Declarations of Conformity are up to date
- Ensure all post-market surveillance and reporting obligations are met
- The PRRC must be at the continual disposal of the organisation and be available at all times to ensure reporting activities are in place.
Outsourcing the PRRC role to a specialised consultancy firm like Med-Di-Dia Ltd. can provide a number of benefits for medical device companies.
Firstly, it allows companies to access a team of experts with a deep understanding of the regulatory landscape. These experts are able to provide guidance and support on compliance-related issues, such as gap assessments, internal audits, and training programs.
Furthermore, outsourcing the PRRC role can save companies time and money. Building and maintaining an in-house regulatory compliance team can be costly, and it can be difficult to find and retain staff with the necessary expertise. Outsourcing the role to a consultancy firm allows companies to access the expertise they need on an as-needed basis, without the need to invest in a full-time staff.
Another advantage of outsourcing the PRRC role is that it allows companies to focus on their core competencies, such as research and development, manufacturing, and marketing. By outsourcing the regulatory compliance responsibilities, companies can free up valuable resources and time to focus on the areas that will drive growth and success.
In conclusion, outsourcing the role of PRRC is a smart move for medical device companies. It provides access to a team of experts, saves time and money, and allows companies to focus on their core competencies. By outsourcing the PRRC role, medical device companies can ensure compliance with the latest regulations and standards, which will ultimately help to protect their reputation and ensure the safety and effectiveness of their products.
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