IMed Consultancy supports Poole Bay Holdings Group in EU MDR auditing and UK Manufacturer validation – 

Established in 1991, the Poole Bay Holdings Group is one of the UK’s leading online and catalogue marketers and manufacturers of products for business, manufacturing, stocking and selling an incredibly diverse range of over 30,000 products via their many websites.

One of Poole Bay Holdings Group’ businesses, MediSupplies, specialises in medical products, leveraging relationships with suppliers and industry professionals to provide the best products to their loyal customers. During the COVID19 pandemic MediSupplies supplied thousands of workplaces, care-homes, schools, hospitals and households with the products they desperately need.

One of the brands manufactured by Poole Bay Holdings Group and provided through MediSupplies is Koolpak, whose Hot&Cold therapy products are regularly used in schools, hospitals, offices and physiotherapy clinics. These products are commonly used by professional and amateur sports teams across the country. In addition, Koolpak are a trusted supplier to NHS Supply Chain, NHS Blood & Transport and the Ambulance Service, having supplied them for over 10 years.

At the end of 2022, Poole Bay Holding reached out to IMed Consultancy as they needed support for o KoolPak’s EU MDR audit. IMed’s team worked closely with Poole Bay Holdings’ compliance experts both before and during the auditing process, also providing in-house support for this delicate but essential process.

“With regulations and relative deadlines continuously changing, having expert regulatory consultants to rely on was a real game changer,” explains Kelly Lyon, Compliance Manager and Pharmaceutical RP at Poole Bay Holdings Group.

While drafting and reviewing the auditing documents, Poole Bay Holdings’ team also realised that IMed’s team could provide additional support for Koolpak’s UK manufacturer validation. This project was scheduled to start at a later date, but,, impressed by IMed’s knowledge and experience, Poole Bay decided to fully leverage their support to steam ahead with manufacturer validation, ultimately reducing overall compliance requirements as well as transport and freight times and costs for the busienss. In the future, Poole Bay Holdings Group plans to expand KoolPak’s UK offering, adding reusable hot&cold therapy products to MediSupplies’ already extensive catalogue.

“We enjoyed working alongside IMed. They are extremely knowledgeable, and really felt like an extension of the team! I will surely miss bouncing around ideas with them but I’m sure we’ll be in touch soon for further collaboration!” concludes Kelly.

“We’re really proud of the work done for – and with – Poole Bay Holdings Group,” says Leeanne Baker, Managing Director and Senior QA/RA Consultant at IMed Consultancy, “Medical Devices manufacturers are navigating a difficult and unpredictable landscape, with deadlines changing overnight and requirements piling up, so we’re always really glad to be able to step in and help them reach their goals!” concludes Leeanne.