IMed Consultancy
Your Trusted Regulatory Partner for MedTech Success

IMed Consultancy is a leading medical device regulatory consultancy, helping manufacturers of medical devices and IVDs achieve and maintain global compliance with clarity and confidence. Since 2012, we’ve partnered with innovators, established manufacturers, and QA/RA professionals to deliver practical, results-driven regulatory solutions.

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The Story of IMed Consultancy

Founded in 2012, IMed Consultancy was created to simplify the complexity of medical device regulation. Over the past decade, we’ve evolved into a dynamic, international team specialising in Regulatory Affairs and Quality Assurance consulting for all classes of devices, from high-risk implants and diagnostics to Software as a Medical Device (SaMD).

Today, IMed Consultancy supports clients across the UK, EU, USA, and global markets, combining technical excellence with a commercial understanding of what drives MedTech success. Our focus is on building long-term relationships, offering guidance that’s compliant and commercially strategic.

Your Flexible Regulatory Partner

We operate as an extension of your in-house team, providing agile, scalable support at any stage of your product’s lifecycle. IMed Consultancy can fulfil critical roles such as EU Authorised Representative (EUAR), UK Responsible Person (UKRP), Person Responsible for Regulatory Compliance (PRRC), and Post-Market Surveillance (PMS) management.

Whether you’re preparing your first submission or managing a multi-country portfolio, our medical device consultants bring the precision, experience, and responsiveness you need to stay compliant and competitive.

A healthcare professional holding a stethoscope points at a document while collaborating with a colleague at a laptop, with a glowing digital network overlay of medical crosses and people icons connecting the elements of the scene.

Driving Innovation with IMed Consultancy

IMed Consultancy’s specialists blend deep regulatory knowledge with real-world commercial insight. We help clients of all sizes, from growing startups to global manufacturers, accelerate innovation while maintaining the highest compliance standards.

Our flexible approach ensures you get exactly the level of support you need, whether strategic advice, documentation, leadership, or full outsourcing. Above all, we focus on solving your challenges with transparent communication, clear timelines, and measurable outcomes.

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“IMed’s expertise and responsive support has been invaluable to our team.”

Meet The Management Team

The success of IMed Consultancy is driven by our leadership. Meet the experienced professionals who guide our strategy, uphold our quality standards, and ensure we deliver value to clients worldwide.