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.

An extension of your team with services ranging from UKRP, PRRC and PMS

We’re 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 mundane. We share the same objectives and drive as your in-house staff and 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 companion diagnostics and digital medical devices (SaMDs). We can help you navigate the world’s regulatory minefields, develop innovative but compliant solutions, simplify your compliance and ensure that you deliver safe and effective medical devices.

Supporting innovation and international market access

Our permanent team of specialists’ regulatory and client skills are industry specific and are reinforced by a great deal of commercial experience. We address the regulatory challenges of our expanding customer base, and we retain clients for many years. We are able to provide expertise for a growing range of new, innovative medical devices across the globe. As a result, IMed goes from strength to strength, cementing client relationships with large international corporates, while also developing easy to understand processes and quality documentation for smaller businesses; taking multiple devices to market every year, all around the globe.

At IMed Consultancy we solve the regulatory challenges of our expanding customer base, by consistently putting their needs, their timelines, and their budget first. We know what it takes to run a business, whilst thinking on our fee to help you meet regulations and get your device to market and for continuing compliance.