ISO 13485 Medical Devices

What is ISO 13485 Medical Devices?

ISO 13485 Medical Devices is the internationally recognised quality management system (QMS) for manufacturers of medical devices and related services. ISO 13485 is the global benchmark for QMS medical devices, with over xx certifications worldwide.

What does ISO 13485 Medical Devices do?

ISO 13485 Medical Devices helps medical device manufacturers provide products and related services that live up to the expectations of customers and regulatory bodies. In particular, the requirements for customer satisfaction and continual improvement have been modified to make them more appropriate for regulatory purposes.

ISO 13485 Medical Devices Benefits

An ISO 13485 Medical Devices certification helps to deliver

• shareholder engagement

• organisational reputation

• client satisfaction and

• competitive advantage

International harmonisation of regulatory requirements help to deliver the benefits of ISO 9001 QMS specifically for manufacturers of medical devices.

Who Can Use ISO Medical Devices?

ISO 13485 Medical Devices is only applicable to manufacturers of medical devices and related services.

How LRQA Can Help

Management systems are becoming increasingly linked to the success and survival of organisations. In parallel, CEOs and MDs worldwide are placing greater emphasis on the independent assessment that helps ensure management systems are 'fit for purpose'. Our unique methodology, LRQA Business Assurance, helps organisations manage their systems and risks to improve and protect their current and future performance. We provide certification and training across all of the major QMS standards.

For organisations with other standards, we can often offer integrated assessments, thus delivering savings on both time and money.