What We do
Assisting you in being compliant
We provide a wide range of high-quality services, such as regulatory consultancy for medical devices and IVDs, and consulting and advice around medical device and IVD compliance. We provide full document generation services such as compliant Technical files, as well as UK Responisble Person Services and EU Authorised Representative Services. We can work with a flexible approach such as a block of time dedicated to helping you or tailored monthly services on retention to help with the cost burden on your business. We can make a service that works for you and your business.
UK Medical Device
USA Medical Device
Europe Medical Device
They provide a pragmatic solution to our needs, are totally reliable & always available to answer our (often simplistic) questions. They are highly efficient & responsive to what is a changing picture in our world and nothing is too much trouble.
We have a much better understanding of regulatory affairs and our responsibilities as manufacturers & distributors and they support us in navigating the requirements in different territories.
Updating our Declaration of Conformity, ensuring our labelling is compliant and acting as our PRRC are the main areas of their service for us."