Providing regulatory and quality solutions to the medical device industry.

Regulatory excellence in global market requirements, covering both established and novel technologies.

We offer a full range of regulatory services from the initial regulatory strategy right through to approval and the post market phase. Our insight into the regulatory requirements will pave the way for a smoother route to market.

Whether you are looking for assistance with internal audits and CAPAs or to delegate the running of your entire quality management system, we can provide the most appropriate solution to help.

From retrospective design documentation for legacy devices to planning the development strategy for your new product, our knowledge of the regulatory requirements for medical device product development will ensure the most efficient use of time and resources.

We are a team of medical device regulatory affairs experts with experience providing a European Authorised Representative service.