IMed Consultancy is a highly knowledgeable medical devices regulatory consultancy with key experience in Regulatory Affairs and QA in medical devices, including Class III, active & implantables, Software as a medical Device (SaMD) and IVDs, founded in 2012. Our team of highly skilled and experienced medical device regulatory professionals, whose focus on client relationships and industry expertise, combine to offer an outstanding yet flexible global regulatory service and consistently support all types of businesses in meeting the requirements of different international regulatory environments from the UK to the EU and the USA, but also further afield.
An extension of your team with services ranging from UKRP, PRRC and PMS
We’re a focussed extension to your in-house regulatory team, but on a flexible, scalable and project basis and have the luxury of not being distracted by the day-to-day mundane. We share the same objectives and drive as your in-house staff and can step in to flexibly support with a range of regulatory compliance tasks from taking care of PRRC and PMS processes to offering UKRP and EUAR services or supporting market entry for companion diagnostics and digital medical devices (SaMDs). We can help you navigate the world’s regulatory minefields, develop innovative but compliant solutions, simplify your compliance and ensure that you deliver safe and effective medical devices.
Supporting innovation and international market access
Our permanent team of specialists’ regulatory and client skills are industry specific and are reinforced by a great deal of commercial experience. We address the regulatory challenges of our expanding customer base and we retain clients for many years. We are able to provide expertise for a growing range of new, innovative medical devices across the globe. As a result, IMed goes from strength to strength, cementing client relationships with large international corporates, while also developing easy to understand processes and quality documentation for smaller businesses; taking multiple devices to market every year, all around the globe.
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.
Meet The Management Team
Managing Director - Senior QA/RA Consultant
Leeanne Baker, the founder of IMed Consultancy, guides the team with her extensive experience in Global Medical Device Regulation and Quality projects, supported by a solid grounding in Industry.
Leeanne can relate to your business challenges and supports your success by advising you on how to demonstrate that your device is safe and your processes are controlled, all with a solid appreciation of the commercial implications of regulatory decisions.
A highly regarded Regulatory and Quality professional and Senior Consultant, Leeanne has a strong belief in the value that industry experience brings to regulatory specialists’ expertise and commercial nous. As a result, she’s built up a well-versed QA/RA team of trusted specialists, who share her desire to perform at the highest level for clients, giving regulatory advice that supports business strategy and direction. Leeanne and all the team at IMed have a genuine passion to participate in delivering safe medical devices, supporting healthcare systems and improving patient outcomes.
‘We know what it takes to run a business, whilst also meeting the appropriate regulations. As a result, we can prioritise getting your device to market, without compromising on our mission to minimise risk and ensure continuing compliance post-market, by encouraging you to take the correct steps from the outset.
“At IMed, we pride ourselves on being a friendly and approachable team of talented industry specialists, who naturally strive to deliver quality with transparency, integrity and even a sense of humour! Our shared professional ethos is a vital ingredient to growing our business and has led to a constant increase in the number of businesses of all sizes, from startups to large corporations, calling on our flexible range of services.”
Business Development Director
After starting her Career in Sales in the City, as a lowly Finance Rep, Al soon climbed the ranks to National Sales & Marketing Director with a leading Premium Finance Business. After spending 15 years as a Sales & Business Growth Coach and Mentor, Al was keen to be part of a permanent team again and was looking for a company with major growth plans in a sector with a meaningful impact on others. Al now supports the business with zest and expertise leading the Sales, Marketing and Development activities and focusing on client and partner relationships development.
‘I’m thrilled to be in such an exciting industry at a time so rich in change and innovation. I really believe that companies like IMed can make a valuable contribution to healthcare at a time of unprecedented social unity for good international health. I was impressed by IMed and the Team’s skill at combining both commercial and patient focus, against a backdrop of high QA/RA standards.’
Al is a theatre and movie fan and just can’t stop cooking delicious food. So, if you are ever hungry…
IVD and MD Consulting Services Director
Jonathan, IMed’s Consulting Services Director, initially started his career in pathology laboratories, before studying for a degree in Microbiology. Now, with 15 years’ experience in Quality Management gained in pharmaceuticals, Defence and In-Vitro Diagnostic Medical Devices, he amassed considerable expertise in managing systems certified to ISO9001:2015 and ISO13485:2016.
Jonathan’s experience in Regulatory Affairs has also seen him working with RT-PCR, Immunoassays and Immunochromatographic technologies, in addition to consulting and helping clients navigating global regulatory requirements; particularly in EU and US.
A lover of music and sport, you’ll often find him “trying” to play bass guitar or cheering on one of his many favourite teams, maybe one day one of them will win something.
With more than ten years’ experience in QA/RA roles, Tim has breadth and depth of knowledge across the regulatory, engineering, clinical, design and development, and quality assurance disciplines. Tim has a passion for empowering innovation in medical devices, and brings insight and pragmatism to projects bringing complex lifesaving and life enhancing products to market.
When not adventuring around medieval castles with his family, Tim is a theatre enthusiast, particularly opera and musicals, and loves a super hot curry!
Strategic Development Director
Matt has over 12 years’ experience in QA/RA specialising in MDD/ UKCA and EU MDR. Representing many clients as UKRP, PRRC and with Global registrations, he’s worked with many devices over his Regulatory career from class I to class III and maintains many lasting client relationships. When he’s not at work, he’s usually surfing on the Devon coastline!
An accountant, a Geophysicist and a teacher, Brian also has experience with medical device manufacturing, providing him with key insight into the challenges faced by the industry. Currently Brian is Operations Director at IMed, manging project and admin resources.
When not in the office you’ll either find him in a forest, an airsoft weapon in hand, or at a hobby desk building and painting models for gaming.
Get in touch to find out how we can work together
Feel free to get in touch with any questions or enquiries you may have or go the old fashioned route and give us a call on +44(0) 1295 724286.
We would love to hear from you!