Regulatory Accelerator Programs

Designed for Startups Bringing Medical Devices or SaMD to Market

Regulatory success doesn’t happen by accident — it requires a clear plan, the right documentation, and deep understanding of local rules. Our Regulatory Accelerator Programme guides early-stage teams through the full approval process in the UK, Australia, and New Zealand.

In a 12-week to 6-month format, you work closely with experienced consultants to:

Define your product classification & regulatory pathway
Build your technical documentation from scratch
Align with IEC 62304, IEC 62366-1, ISO 13485, and cybersecurity standards
Prepare for UKCA, TGA, or Medsafe submissions
Establish post-market systems & quality workflows

Built for real-world execution — not theory.

Build internal expertise to meet UKCA, TGA & Medsafe requirements

Your Questions Answered – What You Need to Know

What is the Regulatory Accelerator Programme?

It’s a hands-on support program for startups developing medical devices or SaMD. We work with you over several weeks or months to build your complete regulatory foundation — from classification to submission.