What is ISO 13485?
ISO 13485:2016 is an internationally agreed standard that outlines the requirements for a quality management system (QMS) for companies in the medical devices industry. It applies to all organisations involved in the design, production, installation and servicing of medical devices.
A medical device is classed as any product which is instrumental in the prevention, diagnosis, or treatment of medical conditions.
There are many benefits to attaining ISO 13485 certification, including demonstrating to those within and outside of your organisation that you meet the standards for regulatory compliance.
Our ISO 13485 Services
Our Systems Division provides 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 training, consultancy, 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 (QMS) 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 companies outside of the UK)
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. Failure to have an appointed responsible person will result in the product no longer being permitted into the UK healthcare market. 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.
