What we do
Two paths, one goal: your approval.
We help medical device and SaMD companies get to market, and stay there. Whether you need to upskill your team or you need hands-on regulatory support, we offer two complementary service tracks.
Two Service Tracks
Training or consulting, or both.
Some clients want to build the capability in-house. Others want experienced hands to deliver the work. Many want a mix. Whatever fits, we adapt.
Track 1
Training & Workshops
Empower your team with hands-on knowledge in regulatory affairs, SaMD compliance and quality management. Build the capability in-house, so you don’t depend on consultants forever.
What’s included
- 1-on-1 coaching sessions
- In-house workshops tailored to your team
- Seminars on MDR, IEC 62304, ISO 13485
- Regulatory accelerator programmes
- Startup Office Hours
- RBP-certified training delivery
Best for
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Track 2
Consulting & Support
Get tailored, no-commitment regulatory advice, from a quick check-in to full compliance support. We can be your extra pair of hands, your external regulatory function, or your in-country representative.
What’s included
- Free initial consultation
- Micro consulting for quick blockers
- Full regulatory strategy & documentation
- Technical file authoring & review
- External PRRC / QMR roles
- In-country representation (UK, AU, NZ)
Best for