Person Responsible for Regulatory Compliance (PRRC) Services

Keep Your Medical Devices Compliant with the Right PRRC Expertise

Meeting your PRRC obligations shouldn’t become another burden on your internal team. Get qualified Person Responsible for Regulatory Compliance (PRRC) support to oversee key regulatory responsibilities and help keep your medical devices aligned with EU MDR and IVDR requirements.

Keep Regulatory Responsibilities Under Control

Know What Your Organization Needs to Stay Compliant

Build a clear regulatory pathway that aligns with your product, target markets, and business objectives before you begin the submission process.

Put the appropriate PRRC oversight in place to support your organization’s obligations under the applicable European regulations.

Keep key regulatory responsibilities under continuous oversight as your devices, documentation, and compliance activities evolve.

Navigate regulatory requirements across international markets with guidance tailored to your expansion strategy.

Keep your regulatory documentation and activities aligned with evolving requirements throughout your product’s lifecycle.

Gain access to the required regulatory expertise without necessarily adding another full-time regulatory position to your internal team.

PRRC services supporting a medical device company with regulatory updates, team collaboration, and ongoing compliance.

Your PRRC Expertise, Without the Full-Time Hire

Get access to qualified PRRC expertise without adding another permanent role to your internal team. Our experts work alongside your organization, giving you the regulatory support you need while keeping your team flexible.

Get the Expertise You Need

Access experienced PRRC professionals without going through the time and cost of recruiting a full-time specialist.

Work Like an Extension of Your Team

Your external PRRC works alongside your internal team, understands your organization, and supports your ongoing regulatory responsibilities.

Scale Support as You Grow

Get the level of PRRC support your business needs today and adapt it as your products, markets, and regulatory responsibilities evolve.

PRRC Support That Fits Your Organization

Every medical device company has different products, processes, and regulatory responsibilities. Our external PRRC support adapts to your organization, working alongside your team to provide the regulatory oversight you need.

1. Understand Your Organization

We start by reviewing your products, regulatory activities, Quality Management System, documentation, and current responsibilities to understand how your organization operates.

2. Integrate with Your Team

Your external PRRC works alongside your internal team, establishing clear responsibilities and communication while supporting the regulatory activities relevant to the PRRC role.

3. Provide Ongoing Regulatory Oversight

As your products and organization evolve, your PRRC continues to oversee applicable regulatory responsibilities and support your team in maintaining compliance with MDR or IVDR requirements.

Extend Your Team with PRRC Expertise

Access qualified PRRC expertise without adding another full-time position to your internal team. Get the regulatory oversight your organization needs while keeping your resources focused on developing and growing your business.

Qualified PRRC Expertise

Work with professionals who understand EU MDR, IVDR, medical device compliance, and the responsibilities associated with the PRRC role.

Flexible PRRC Support

Get ongoing PRRC support adapted to your products, regulatory activities, and changing business needs without building a larger internal team.

Integrated with Your Team

Your PRRC works alongside your existing quality and regulatory functions, with clear communication and coordination across relevant compliance activities.

Focused on Ongoing Compliance

Maintain regulatory oversight as your products evolve, documentation changes, and post-market activities generate new compliance responsibilities.

Get the PRRC Expertise Your Business Needs