Regulatory Fundamentals Program

Applications open

4 live sessions 60 min each - 4 weeks Max 15 participants One clear roadmap

The Regulatory Fundamentals Program is a live online course designed for medical device founders, product managers, and technical leads who need to understand the regulatory landscape — but don't have a regulatory background. Over four weekly sessions, you'll learn how devices are classified, what documentation is required, and how to build a realistic roadmap to market access in the EU or UK. Each session is interactive, small-group, and led by a practising regulatory specialist.

Option 1 - Starter

Foundation

For founders who want to learn independently

£697

Ideal if: you prefer self-directed learning, have a limited budget, or want foundational regulatory knowledge first.

✓ 4 live online sessions (60 min each)
✓ All course materials & templates (PDF)
✓ Session recordings - 30-day access
✓ General Q&A during sessions
✓ Certificate of completion

Expert Consultation

For founders ready to take action on their product

£1,297

Ideal if: you have a specific product to review and need personalised guidance tailored to your device or SaMD.

✓ Everything in Foundation
✓ Session recordings - 90-day access
✓ 1-hour professional consultation
✓ Review of YOUR product classification
✓ YOUR specific regulatory pathway discussed
✓ Personalised recommendations
✓ Preliminary Intended Use Statement review

FAST START

Option 3 - Elite

Expert Consultation + Fast Start

Best for: Founders ready to move quickly

£3,000

Ideal if: you are ready to move fast and want the deepest level of personalised support to accelerate your regulatory journey.

✓ Everything in Expert Consultation
✓
2-hour strategy session (instead of 1 hour)
- Deep dive into your product
- Draft Intended Use Statement together
- Preliminary classification analysis
- Customised 90-day action plan
✓ £200 credit toward DocPack service