ISO 13485 Medical Devices is designed for businesses which provide medical devices and related services (such as maintenance and repair).

Holding this standard demonstrates that you consistently meet both customer and regulatory requirements in your field. It also demonstrates how you meet legal requirements in the field.

Specifically, the standard relates to you if you’re involved in the design, development, production, installation and servicing of medical devices.

Similar in scope to ISO 9001 Quality, but adapted to suit the medical industry, this standard works to bring together the needs of your customer with what you deliver as an organisation.

Implementing this standard requires you to set up a framework through which your customers can provide feedback, positive or negative. You’ll also have to react to this feedback and use it to make improvements at regular intervals at a managerial level. You’ll also have to ensure that your in-house operations work to satisfy the needs of your customers and that, again, incremental improvements are taken at management review.

ISO 13485 Medical Devices is also often used as a way to demonstrate the required controls and technical competence required in support of a CE marking for medical devices to allow them to be sold in the EU and even further afield. See our UKCA/CE Marking page for more information.

Operating within a medical device field and holding ISO 13485 Medical Devices sends a clear message to your customers that you operate within the required legislation and your business is consistently meeting customer expectations.

ISO 13485 Medical Devices is designed to be adaptable and is open to all companies, large and small, who do business within the medical device sector.