IMed Consultancy, a UK based highly knowledgeable medical devices regulatory consultancy is at Medica 2023 where they will be presenting their regulatory consultancy and QA offering, with special focus on their UKRP services for international businesses wishing to enter the UK market. IMed’s UKRP offering combines experience with wider international regulatory knowledge, helping businesses to expand globally.
With extensive experience supporting UK and international medical device and in vitro diagnostic manufacturers, IMed identified a need to provide the manufacturing industry, and specifically businesses wanting to launch or keep a medical device on the UK market, with an experienced UKRP.
“We’re really excited to be able to spread the word about our already popular UKRP service as international businesses will be exploring the potential of the UK market in the ABHI pavilion at Medica” says Al Mills, IMed’s Business Development Director. “We’re confident we can help international businesses navigate the UK’s regulatory landscape, develop innovative but compliant solutions and successfully enter the UK market. And we can support global submissions in many other territories, so our clients can come to us for advice wherever they want to sell next!” continues Mills.
A UK Responsible Person, or UKRP, is in fact a requirement for ensuring a medical device can be placed and maintained on the UK market. The UKRP acts on behalf of businesses based outside the UK to carry out all tasks needed to successfully place their device on the UK market and keep it compliant, liaising with entities such as the MHRA, so choosing the right partner to act as your UKRP can really make all the difference.
IMed Consultancy’s team is a focussed extension to your in-house regulatory team, but on a flexible, scalable and project basis and have the luxury of not being distracted by the day-to-day tasks. Sharing the same objectives and drive as your in-house staff, IMed can step in to flexibly support with a range of regulatory compliance tasks from taking care of PRRC and PMS processes to offering UKRP and EUAR services or supporting market entry for borderline products, companion diagnostics and digital medical devices (SaMDs).
IMed’s permanent team of specialists’ regulatory and client skills are industry specific and are reinforced by a great deal of commercial experience. As a result, IMed is able to provide expertise for a growing range of new, innovative medical devices across the globe, solving the regulatory challenges of their expanding customer base, by consistently putting their needs, their timelines, and their budget first.
Want to know more? Make sure to stop by at IMed Consultancy’s stand H52-7, hall 16!
About IMed Consultancy
IMed Consultancy is a highly knowledgeable medical devices regulatory consultancy with key experience in Regulatory Affairs and QA in medical devices, including Class III, active & implantables, Software as a medical Device (SaMD) and IVDs, founded in 2012. Our team of highly skilled and experienced medical device regulatory professionals, whose focus on client relationships and industry expertise, combine to offer an outstanding yet flexible global regulatory service and consistently support all types of businesses in meeting the requirements of different international regulatory environments from the UK to the EU and the USA, but also further afield.