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.’
Stephen Quinn is our resident IVDR expert. He is a cricket enthusiast with a passion for cooking and gardening.
Stephen has over 18 years’ experience working within the IVD industry including management roles in Quality and Regulatory Affairs. He has a practical knowledge of Quality Management Systems, IVDD, IVDR, MDSAP, CE marking and global regulatory submissions.
Catriona Underwood is our MDR expert. She loves to sail and has a dinghy in her garden, although she’s hoping one day to have a much bigger boat!
As one of the few who always intended to have a career related to medical devices, rather than stumbling into it by chance, Catriona was always destined to work in this industry. From a young age, she had a fascination with hospitals and all things medical, leading her ultimately to study for an MEng in Biomedical Engineering. She was initially involved with designing, developing and manufacturing medical devices, as an engineer, but moved over to Quality Assurance and Regulatory Affairs. With a genuine passion for medical devices and unique background of both engineering and QA/RA, Catriona knows the challenges of getting a device to market and really does understand the commercial and practical aspects of the business, from a manufacturer’s perspective. She’s particularly interested in MDR and MDSAP requirements and stays right up to date with any regulatory updates.
Has a broad range of experience in medical device regulatory affairs across global territories, including advising on regulatory requirements, preparing regulatory submissions, and involvement in MDSAP certification and compliance.
Kate loves all aspects of the product life-cycle and how regulations impact each one, but has a particular passion for supporting clients to achieve their business goals by securing registrations or certifications in new territories. She also has an interest in learning about emerging challenges for our sector, such as cybersecurity and technological developments.
When not helping our clients, Kate has a love of baking and being on the beach in her hometown.
RA & Clinical Consultant
Ana started her working life in a lab; with food and pharmaceuticals. But once she started getting involved with notified bodies, audits and re-writing SOPs, she was hooked on Clinical! Ana is a microbiologist with a degree in bio-med sciences, completing her Masters, in Clinical Microbiology in 2020. Her dissertation was a research project entitled ‘Assessment of bioburden validation studies on medical products: Evaluation of different methods and their efficacy, challenges, and limitations’. As a Senior Medical Writer at NAMSA, she’s authored numerous Clinical Evaluation Reports, as technical Lead – following through from the plan to the report itself; liaising closely with clients and notified bodies. Ana has experience dealing with issues like non-conformities, MDD/MDR transitions, PMS plans and PSURs. She’s also developed specific PSUR templates.
Ana hails from Portugal originally but has now settled here in the UK in Tamworth. A long-time gamer, she actually met her husband in a Dungeon! Not many people can say that…. Ana is a dog lover and also enjoys all kinds of Arts and Crafts, particularly drawing and painting.
Rebecca Munro Stearn
Operations and Project Manager
Rebecca joined IMed with an eclectic mix of experience in arts, education, aerospace, Health and HR. She spent over 10 years in project management seeing her manage a £52m fundraising campaign for the Royal National Theatre. But her skills extend to a broad list, usually involving her assisting with establishing new teams, offices, creating systems and processes. She has had supporting roles complying with quality management standards too. Rebecca also spent 3 months establishing a new European office for a HR company in Granada, Spain.
She is at her happiest in a museum or gallery, having studied History of Art at Oxford and still harbours vague dreams of returning to complete her PhD one day.
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…….
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!