IS THIS YOU?
Do you have a new medical device and are not sure how to get it to market as quickly and cost-effectively as possible and comply with the regulations?
Are you struggling with transitioning to the new MDR/IVDR Regulations for Europe and don’t know where to start?
You have had your Technical File reviewed and had non-conformance’s raised and are not sure how to action them?
Are you struggling with your Quality Management System, do you need help to stay on top of your CAPA’s and internal audits?
These are some of the problems I solve for my clients. With the constantly changing regulatory landscape it is often difficult for companies to keep up with current requirements or have the available resource to do so. That’s where we can help.
IMed was founded in 2012 when I recognised the need to help small businesses and those new to the medical device industry navigate the regulatory minefield, simplify compliance and deliver safe and effective devices to market.
The team consists of associates and specialists whose skills are specific and fine-tuned. All members of the team have industry experience. We’ve 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.
And we pride ourselves on being a friendly, close team of talented and driven people that strive to deliver quality with honesty and integrity.
WHO WE ARE
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.
Managing Director - Senior QA/RA 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 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.
Let’s Start Something new
Feel free to get in touch with any questions or enquiries you may have or go the old fashioned route and give me a call on +44(0) 1295 724286.
I would love to hear from you!