ISO 13485

Our Systems Division provide Medical Device Services to help customers with the highly technical and sometimes complex field of medical device management system development. 

Our subsidiary (QCS International)  has, for many years, been a leading provider of medical device consultancy, training and regulatory advice to businesses operating within the medical device, sterile and healthcare sectors.  Our consultants have been involved in the regulatory aspects of new to market medical device innovations as well as supporting existing products in an ever more complicated regulatory framework.

We have the ability, experience and expertise to install a quality management system for your company – which can be used to allow you to demonstrate conformance with ISO 13485 as well as the FDA Code of Federal Regulation, title 21, Part 820.

Responsible Person Service (for clients outside of the EU) 

Manufacturers of medical devices who are not located within the UK must appoint a ‘UK Responsible Person’ to act on their behalf and to register their devices with the relevant UK regulatory body.  The specialists within our Systems Division (QCS  International) are registered with the Medicines and Healthcare Regulatory Agency (MHRA) to act as a responsible person and to complete the registration process.  Failure to have an appointed responsible person will result in the product no longer being permitted into the UK healthcare market. If you are looking for support, then this service is for you.

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