IMed Consultancy helps medical device manufacturers bring safe, effective products to market with confidence and continuity. As a specialist medical device consultancy, we combine deep technical understanding with practical, results-driven regulatory guidance. Whether you’re developing a new device, improving an existing one, or expanding into new regions, our experts make compliance faster, clearer, and more achievable.
Expert Support for Every Stage of Your Device’s Lifecycle
Our team of experienced medical device consultants provides end-to-end support, acting as an extension of your in-house QA/RA function. We offer clear, actionable guidance through every step of product development and market access so you can focus on innovation while we handle compliance.
We can help with:
Staying Ahead of MDR Regulation
Regulation (EU) 2017/745 (MDR) introduced new demands for medical device businesses, from stricter clinical evidence requirements to ongoing surveillance and reporting. IMed Consultancy has supported clients through every phase of MDR compliance, providing structured actionable advice that keeps products compliant, documentation audit-ready, and teams informed.
Whether you’re starting fresh or adapting legacy devices, we’ll help you identify regulatory gaps, prepare submissions, and train your staff for the new compliance landscape.
Why Choose IMed Consultancy?
At IMed Consultancy, we do more than manage paperwork. We build partnerships. Our clients trust us to understand their business and products. That’s why many return to us project after project, relying on our mix of technical precision and practical, human support.
We’re known for:
Our Medical Device Expert
Caroline Timberlake
Caroline brings over 15 years of experience in the pharmaceutical and medical device industries, with deep expertise in regulatory affairs and quality assurance. At Imed, Caroline leads our consulting services, ensuring clients receive high-quality guidance and support as they navigate complex regulatory requirements.
Get the Right Regulatory Support
Whether you need help with ISO 13485 quality management system, international registration, or regulatory remediation, IMed Consultancy offers the full scope of medical device consulting. We provide both strategic and hands-on support, from day-to-day consulting to acting as your long-term regulatory partner.
Frequently Asked Questions
Regulatory pathways can feel complex, even for experienced teams. To help you understand what to expect when working with a medical device consultancy, we’ve answered some of the questions our clients ask most often.
A medical device consultancy like IMed provides expert support to help manufacturers bring products to market safely and compliantly. This includes regulatory strategy, documentation, quality management, and ongoing post-market compliance. In short, we make complex regulatory pathways clearer, faster, and easier to manage.
The most valuable time to involve a medical device consultant is right at the start, during device concept. Early regulatory input helps align your regulatory and commercial strategy from day one, reducing rework, streamlining documentation, and ensuring your development plan is built around global regulatory requirements.
Yes. IMed has extensive experience helping clients transition from MDD to MDR and maintain ongoing compliance. Our team can perform gap analyses, update technical documentation, prepare submissions, and train your staff on the new MDR requirements.
Absolutely. IMed Consultancy supports medical device companies in the UK, EU, USA, and other global markets. Whether you need UK Responsible Person (UKRP) services, representation in the EU, or strategic guidance for multi-region submissions, we’re equipped to help.
Our pricing depends on your project’s size, device classification, and regulatory scope. We offer flexible models, from short-term consulting to retained support, so you only pay for what you need. Get in touch to discuss a solution tailored to your goals and budget.
Our clients tell us it’s our people. Every IMed consultant has real-world industry experience, not just regulatory theory. We work as an extension of your team, providing practical, transparent guidance that balances compliance with commercial success.
Ready to Get Started?
Let’s make your next medical device project faster, smoother, and fully compliant. Tell us what you’re developing and we’ll show you the clearest route to approval.