About Us

We are a small, friendly, family Limited Company set up in the middle of 2019 to help small businesses meet the ever-changing regulatory challenges of medical devices. 

We understand the frustration and overwhelming feeling that regulatory paperwork can instill in a small company trying to get a medical device on the market. Our aim is to help you get your product to the patients who need the best medical device technology available.

Experience

The Managing Director Stuart has been working in quality and regulatory for over 30 years, more than 25 of these have been in the medical devices industry with well over 1,000 medical devices CE marked to date. He has spent over 20 years specialising in reusable, single-use and implantable devices in the ophthalmic and decontamination industries. The remainder has been focused on other industries such as medical filtration, wound care and respiratory devices.

Alison joined Gemica Consulting Limited in February 2022 and brings with her over 20 years of experience in medical devices. She has worked as Head of Regulatory and Quality worldwide for Leica Microsystems and Head of Regulatory Affairs for the Innovia Medical group.

Together we have taken ideas from customers and turned them into fully functional CE-marked products being used worldwide today. As well as helping to build your technical file we can also help source manufacturing, biocompatibility, testing and sterilization services. Our customers are currently located in the UK, Europe and the United States of America.

Contact 

Stuart at stuart@gemica.co.uk

Alison at alison@gemica.co.uk 

Gemica Consulting Limited is a Limited company Reg: 1213731 established in August 2019

VAT number: GB358209680