A Guide to Medical Device Regulation Webinar

Posted on 13th October 2025

Medical Device Regulation Support - How to Translate Innovation into Regulatory Success

Bringing a new medical device to market can be challenging for start-ups, university spin-outs, and emerging MedTech companies. In this webinar, hosted by PHARMExcel (an experienced UK CRO for medical device clinical trials) in partnership with Imperial College London and HybridNeuro, we provide practical guidance on navigating the complex UK, EU, and US regulatory frameworks.

What you’ll learn:

How to navigate UKCA, CE marking, and FDA approval pathways
Building a quality management system (QMS) that accelerates compliance
Clear device classification examples for first-time innovators
The role of clinical evaluation in market access and growth strategy
Global submission strategies for smoother regulatory approvals

Medical Device Regulation Support - How to Translate Innovation into Regulatory Success

Speaker: Yvanne Enever, CEO of PHARMExcel – experts in clinical research and regulatory strategy for MedTech.

This free webinar is ideal for: Biotech spin-outs | Early-stage MedTech start-ups | Researchers seeking regulatory clarity

Whether you’re preparing your first medical device clinical trial or scaling up your regulatory strategy, this session offers expert insights to help you move from innovation to market success.

Need more in-depth guidance in regulatory submissions, funding or clinical trial design?

Talk to our medical device team

FAQs

What is medical device regulatory support?

Medical device regulatory support helps innovators understand and comply with UK, EU, and US regulations. It covers everything from device classification and Quality Management Systems (QMS) to clinical evaluation and global submission strategies.

Why do start-ups and spin-outs need regulatory support?

Early-stage MedTech companies often face complex regulatory requirements. Expert support ensures your medical device meets compliance standards, avoids delays, and reaches patients faster.

How can PHARMExcel support medical device clinical trials?

As a UK CRO, PHARMExcel provides full-service support for medical device clinical trials, including regulatory strategy, study design, trial management, and quality assurance, ensuring compliance with UKCA, CE, and FDA requirements.

What are the key differences between UK, EU, and US regulations?

UK regulations focus on UKCA marking, the EU requires CE marking under MDR/IVDR, and the US follows FDA pathways. Each has different requirements for clinical evidence and submissions, making expert guidance essential.

How does clinical evaluation fit into regulatory approval?

Clinical evaluation demonstrates the safety and performance of your device. It’s a core requirement for UKCA, CE, and FDA approvals and is critical for market access.