About US

Meet The Team

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.

We pride ourselves on being a friendly, close team of talented and driven people that strive to deliver quality with honesty and integrity. Feel free to talk to our other clients and see what they think about IMed’s performance.

Leeanne Baker

Managing Director – Senior QA/RA Consultant

Headed up by me, Leeanne Baker, a self confessed coffee and chocolate addict and Quality and Regulatory Consultant with extensive experience of both quality and regulatory projects.

I work with a trusted team of specialists. Our skills are specific and fine tuned. We are all industry experienced, we have been there, walked the walk not just talked the talked. 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.

We pride ourselves on being a friendly, close team of talented and driven people that strive to deliver quality with honesty and integrity.

 

 

 

Stephen Quinn

IVDR Consultant

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

MDR Consultant

Catriona Underwood is our MDR expert.  She loves to sail and has a dinghy in her garden.  She’s hoping one day to have a bigger boat!  From a young age, Catriona had an interest in hospitals, leading her to study Biomedical Engineering.  She’s been involved with designing, developing and manufacturing medical devices.  This was before she moved over to Quality Assurance and Regulatory Affairs.  She’s particularly interested in MDR and MDSAP requirements and stays up to date with regulatory updates.

If you would like to find out more about the services and support we can provide, get in touch now.  Call us on 01295 724286 or email us at hello@imedconsultancy.com.

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Say Hello!

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!