- Lack of eligible internal staff
Many companies don’t have a qualified person who meets the regulatory requirements to act as PRRC or QMR. - Unclear post-market obligations
You’re not sure what responsibilities remain after certification – or who should take them on. - Risk of non-compliance
Without a designated representative, you may fall short of local legal requirements or face approval delays. - Regulatory queries go unanswered
Authorities may expect a local point of contact — especially for issues related to vigilance, updates, or audits.
Meet regional requirements with experienced regulatory representation
If you’re placing medical devices or SaMD on the market in the UK, Australia, or New Zealand, you may need to appoint a formal regulatory contact — like a PRRC (UK) or QMR. We take on this role for you and ensure ongoing compliance after certification.
Your Challenges
How We Help
- We act as your official PRRC (UK) or QMR
We formally represent you under UKCA requirements – with full responsibility for regulatory compliance oversight. - We support your post-market activities
From vigilance reporting to technical file maintenance – we stay actively involved to ensure continued compliance. - We liaise with authorities
We handle communication with MHRA, TGA or Medsafe – acting as your trusted partner in regulatory matters.
What Our Representation Covers
Legal Role & Accountability
Formal appointment as PRRC (UK) or QMR for your company.
Post-Market Surveillance Support
Ensure your PMS/PMCF obligations are met and documented properly.
Technical File Oversight
We keep your documentation compliant, up to date, and ready for inspection.
Communication With Authorities
We respond to queries and facilitate regulatory audits or reviews.
Ongoing Regulatory Updates
We monitor local regulation changes (UKCA, TGA, Medsafe) and advise you proactively.
Seamless Integration With Your Team
We collaborate with your internal RA/QA or consultants — no unnecessary overhead.
