Navigating Regulatory Approval: Your Roadmap to Market
Getting regulatory approval is one of the biggest hurdles for any new medical technology, but with the right strategy, it can be a fast-track to market success rather than a roadblock.
This live session will show you how to turn complex regulatory requirements into a clear, actionable plan so you can launch with confidence in the UK, EU, US and beyond. You’ll come away with practical insights, expert advice, and a “how-to” roadmap to guide your approval journey.
You’ll gain clarity on the questions that make-or-break regulatory approval, including:
- What counts as a medical device and why it matters.
- How to determine your device classification.
- Step-by-step guidance on securing UKCA and CE marks.
- Key differences between UK, EU and US processes (including FDA approval).
- The evidence, documentation and technical files regulators expect.
- Who needs to be involved and when.
Special Guest: Acorn Compliance
We’re excited to be joined by Acorn Compliance, experts in making compliance simple and accessible for healthtech innovators.
Acorn will introduce their new Squirrel 2.0, an automated compliance coach, which helps companies meet NHS standards quickly and effectively.
They’ll share:
- How automation can cut time and cost in compliance processes.
- Real-world tips for navigating DTAC and NHS requirements.
- Insights into building a compliance culture that grows with your business.
Who Should Attend?
This webinar is designed for:
- Healthtech and life sciences companies preparing to launch products or services in the UK, EU or US.
- Innovators at concept stage who need a clear picture of the regulatory pathway ahead.
- Teams in the development phase seeking to avoid delays and get to market faster.
Turn regulation from a barrier into your competitive edge.
Secure your ticket today and get one step closer to market approval.
MEET THE SPEAKERS
Chris Warwick, Senior Consultant. Health Tech Enterprise
Chris’ experience includes developing a prototype sensor for use by the water industry where he conducted research and explored methods to help overcome market entry barriers. He also has nearly twenty years’ commercial experience in customer facing roles, including ten years in a consultative account management role for a high tech IT company.
With over 25 years experience in healthtech supporting innovators of all sizes, NHS Trusts, care providers, investors and NHS England, Michael is a veteran in advising and delivering on all aspects of UK HealthTech compliance and regulation. Presently working with global healthtech innovators to assure compliance with NHS DTAC, HIPAA, ISO standards and Medical Device Regulations, Michael is passionate about educating on all things compliance and helping remove barriers to market entry for innovators of all sizes.
If you have any questions about our courses or if you’re interested in booking multiple individuals for a transformative learning experience, we’re here to assist you. Reach out to us at enquiries@healthtechenterprise.co.uk, and our dedicated team will provide you with the information you need.
NHS trusts that are subscribers of Health Tech Enterprise’s services enjoy the exclusive benefit of complimentary attendance to this event.
