IMed Consultancy was founded in 2012. We have a team of highly skilled and experienced medical regulatory professionals, whose focus on client relationships and industry expertise combine to offer an outstanding yet accessible global regulatory service. We find that our function is akin to having your own, in-house regulatory department, but which costs less, because you only use us when you need us. IMed can help you navigate the world regulatory minefields, simplify your compliance and ensure that you deliver safe and effective medical devices.
Our permanent team of specialists regulatory and client skills are industry specific and are reinforced by a great deal of commercial experience. We tackle the regulatory challenges of our expanding customer base (which has grown organically; purely based on personal recommendation) and we retain clients for many years, by consistently putting their needs, their timelines and their budget first. We also work regularly with other specific discipline experts when the need arises, because team working is a core competency for us and it enables us to have a lean cost base at heart, translating into fair pricing for all.
IMed goes from strength to strength, cementing client relationships, developing easy to understand processes and quality documentation; taking multiple devices to market every year, all around the Globe.
We know what it takes to run a business, whilst meeting the regulations in order to get your device to market and for continuing compliance. This marriage of theory and practice is critical to our strategic approach. Tap into our combined 50 years of hands-on problem-solving expertise and we can help your business here in the UK, in Europe or anywhere else in the World.
Meet The Team
Managing Director - Senior QA/RA Consultant
IMed’s Quality & Regulatory Guru and Founder is Leeanne Baker, a self-confessed coffee and chocolate addict. Leeanne has a plethora of experience with Global Medical Device Regulation and Quality projects, backed up by a solid grounding in Industry; so she can relate to your business challenges, whilst advising you how to demonstrate that your device is safe and your processes are controlled.
A highly regarded Regulatory and Quality professional and Senior Consultant, Leeanne has a strong belief in industry experience adding value to regulatory specialists’ expertise and commerciality. So, 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 with relevance to the day-to-day design, production and sales processes. 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. And, we can prioritise getting your device to market, whilst still minimising risk and ensuring 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 close team of talented industry specialists, who naturally strive to deliver quality with honesty, integrity and an ever- necessary sense of humour. This common professional ethos has been a vital ingredient to growing our business and has led to IMed’s numerous long-standing client relationships, which we value and nurture for the long term.’
Business Development Director
Al started her Career in Sales in the City, as a lowly Finance Rep with Lombard, and ended up as National Sales & Marketing Director at Close Brothers Bank’s market leading Premium Finance Business! Spending the last 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 worthwhile sector. And IMed fit the bill! We are now making good use of her Sales, Marketing and Development skills within the business, with client relationships firmly at the centre of all our plans.
‘I’m thrilled to be in such an exciting industry in a period of such immense change. 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 back drop 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…….
Director of In-Vitro Devices
Jonathan is our Head of IVDs. 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.
Jonathan 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 has managed systems certified to ISO9001:2015 and ISO13485:2016. Jonathan’s recent experience in Regulatory Affairs has seen him working with RT-PCR, Immunoassays and Immunochromatographic technologies, prior to joining IMed. He also has previous experience in consulting and helping clients navigating global regulatory requirements; particularly in EU and US.
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 UK RP, PRRC and with Global registrations, he’s worked with many devices over his Regulatory career from class I to class III and maintains many client relationships long term. When he’s not at work, he’s usually surfing on the Devon coastline!
Jade has truly risen through the medical device manufacturer regulatory ranks, having spent 11 years with a specialist compression and wound dressings company. Her product portfolio included Class l and Class llb products and she became a transition expert, as they all moved to UKCA & EU MDR. Jade has Quality experience in ISO 13485, ISO 9001 and ISO 14971 and in UK Responsible Person Services. She’s also an audit veteran with Notified Body, internal/external, supplier and Competent Authority audits under her belt too. Not just Queen of the audits, Jade is also a TV Drama Queen and an HD Brow Specialist, so even when she’s frowning over an MDR Technical file, hers still look perfect.
Senior QA/RA Consultant
Caroline has a degree in Biochemistry and after graduating, she spent 9 years working her way up the ranks in a large medical device and pharmaceutical company, going from QA Officer to Principal Compliance Officer ultimately. Caroline joined IMed after spending 4 years as Head of RA at Summit Medical. As a result, she has stacks of Regulatory and QA experience over many devices and is an MDR transition expert.
Rachel entered the QA/RA arena via prior careers in software, business analysis, project management, process improvement and then setting up a Quality Management System for a medical device manufacturer! She’s since been involved in a wide range of different medical devices and IVDs for different conditions, using varied technologies, manufacturing processes etc. She’s seen the regulations and standards change; with software playing an ever-increasing role in medical devices and IVDs. As one of our specialist software consultants, her experience with a variety of software and AI is invaluable to IMed’s clients; including Clinical Evaluation of SaMDs. Rachel is experienced with the UK, EU and US Regulatory pathways and outside work enjoys yoga, cycling, walking, singing and anything chocolate-related!
Michelle 'Shelley' Campbell
Shelley started her career at Smith & Nephew in Advanced Woundcare and worked her way through the device classes, up to Class III in her next role with ConvaTec. She’s worked with Philips in their Image Guided Therapy RA team and eventually moved into software as medical devices culminating into her last role as RA Manager at Holberg EEG, where she was responsible for everything RA related, for a new SaMD.
Samreen is a Quality and IVD expert.
Daniel is a Consultant in our medical device team. He started his medical device life as Labelling & Artwork co-ordinator at Johnson & Johnson and ended up as a Global Registrations Specialist. He had a cross departmental role, working with current and emerging markets and dealing with change impact for over 90 market registrations for things like; MDR updates, change requirements and the effects of Brexit. Dan loves to travel and is an avid park-runner and Star Wars fan, which means he is a bit of an expert with a lightsabre.
Jacob graduated from Sheffield University with a Master’s degree in Medical Genetics; although much prefers to think of his degree as being more orientated towards general molecular biology. His 4th year dissertation was a bioinformatics project which involved teaching himself python for the design of a functional error-prone PCR simulator for use in laboratory projects aiming to discover more about antibiotic resistance in Streptococcus pneumoniae! Finding himself enjoying and excelling when writing scientific assignments, Jacob realised that he was going to be a medical writer and is now busy with Clinical Evaluation Reviews and Post-market Surveillance Reports at IMed!
Jacob is an avid football player, gamer, and hiker/adventurer. You’ll find him most weekends agonisingly watching Fulham get relegated from the Premier League.
Marketing & Events Manager
Ellie takes care of IMed’s Marketing & Client Communications. She has lots of customer facing & digital marketing experience, which she gained across a number of sectors, but she latterly worked with a specialist laser medical device manufacturer producing thulium veterinary lasers and laser therapy cap devices for hair-loss. Now she’s all about helping patients. She’s a movie and theatre enthusiast, having also gone to Acting School for 2 years, and is mad about animals – most particularly dogs!
Sales Co ordinator
Darren has a long history in client facing roles and particularly in Sales Support. He follows up all our new business enquiries and helps new clients to get the advice they need for their QA/RA projects.
Although he’s a charming and helpful member of the Sales Team by day, you’ll see a different side of him at the Gym, putting participants through their paces running circuit classes and keeping super-fit.
Brian Is Head of Operations at IMed, which means he’s in charge of the projects and Admin Teams. Luckily, he also has a Medical Device Manufacturer background so he appreciates your challenges only too well. But Brian is no one-trick pony; in his early career he’s been an accountant, a Geophysicist and a teacher. 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.
Luke Mallett White
With a background in Admin and Relationship Management, Luke brings an enthusiasm for fostering client relationships and a talent for problem solving to IMed. He enjoys the challenges involved in getting medical devices and IVDs to market and making sure consultants AND clients stay n track.
Hailing originally from Mallorca, Luke is a keen scuba diver, gamer and a Marvel fan. Oh and he makes a great cocktail or two!
Jodie looks after IMed’s bills – in and out – whilst also studying towards her AAT Level 4! She’s a dedicated bookworm when she’s not in demand by her menagerie at home, which includes 2 horses, 4 cats, a dog and 4 fish!
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!