From first concept to global market access, IMed Consultancy helps startups, scale-ups, and established manufacturers achieve compliance with clarity, speed, and confidence.
Since 2012, IMed Consultancy has been a trusted medical device regulatory consultancy, guiding companies across the UK, EU, USA, and beyond.
“I want to thank you for your personal support and the excellent work that Jonathan has done, he has been fantastic and a great ambassador for IMed. I’m sure that in the coming weeks and months Bilistick will be adopted by many midwives and clinicians in hospitals around the country and will prove to be highly beneficial in the care of these small patients.
I hope we can meet up sometime so we can show you the device and discuss other possibilities of working together in the future.”
“SureScreen Diagnostics worked closely with IMed in the process of gaining an Exceptional Use Authorisation from the MHRA for the SureScreen SARS-CoV-2 Rapid Antigen Test Cassette. This involved pulling together and evaluating numerous data sets from Usability and Clinical Evaluation Studies, alongside optimising the technical file and Instructions For Use for the self-test device.
‘IMed have a great team who are very knowledgeable about the regulations for IVDs, and we were able to work with them like they were an extension of our own team which worked really well in practice. They were invaluable in helping us move so quickly to address the market need.The team at IMED were always very helpful, easy to contact, and they went above and beyond to ensure that the process was as smooth as possible and deadlines were met.”
“The IMed team have helped us, and our global suppliers, to navigate the new regulatory burden and transition from MDD to MDR. They have managed the process throughout presenting workable solutions, enabling us to focus on our key business objectives. I look forward to working with them for our ISO13485 certification and wouldn’t hesitate to recommend the IMed team to deal with any Quality and /or Regulatory need.”
“Without the help and expertise of Leeanne and her team it would have taken us significantly longer to reach our goal, we would recommend IMed Consultancy to anyone needing help in navigating the challenges and pitfalls involved in meeting the current requirements for technical files in medical devices.”
“Leeanne has solid experience in quality systems for development and manufacture of sterile medical consumables, and was able to tailor the SOPs and documentation systems to fit our product characteristics and scale.”
Clear, actionable roadmaps to approval, from device classification to evidence and submissions.
Strategic regulatory consulting for medical devices entering new international markets.
Build and maintain ISO 13485 and US Quality Management System Regulation (QMSR) systems, handle audits and ensure ongoing compliance.
At IMed Consultancy we solve the regulatory challenges of our expanding customer base, by consistently putting their needs, their timelines and their budget first. We know what it takes to run a business, whilst thinking on our fee to help you meet regulations and get your device to market and for continuing compliance.
We break down your regulatory pathway into easy-to-understand, practical steps.
Get direct access to senior consultants and real-time updates.
We take ownership and deliver so that you can focus on innovation.
We cut through the noise with straightforward, actionable advice.
Our process is transparent, responsive, and results-driven.
Meet the team behind IMed Consultancy. With decades of combined experience, we’re known for being sharp, approachable, and results-driven.
Insights and guidance from the regulatory frontline.
Whether you’re a first-time founder or a global regulatory leader, we’ll help you move quickly and confidently through compliance.
