ISO 13485 Medical Devices

The medical device industry is affected by a complex array of regulatory systems, national and international standards and other requirements. We provide services that help manufacturers understand what they need to do to place compliant devices on markets throughout the world.

ISO 13485:2003 is the latest version of ISO 13485, published in July 2003.  This standard is based on the ISO 9001:2000 process model approach.

We are formally recognized under the regulatory systems of Europe and Canada and are committed to seeking formal recognition under the USA and Japanese regulatory systems as they evolve and the opportunities arise.

Whatever devices you produce, as a medical device manufacturer you have a responsibility to consistently deliver devices that are safe and effective. ISO 13485:2003 is the international standard recognized for medical device regulations around the world.

Effective quality management systems are recognized as a key regulatory consideration for allowing medical device manufacturers to market their products around the world. ISO 13485 provides a focus for the quality management system requirements for medical device manufacturers.

BSI Management Systems Training can provide training to help you implement a successful Medical Devices Management System. Select a link below to find out more.

Courses Offered:

Understanding Medical Devices Management Systems - ISO 13485

ISO 13485 Internal Auditor

Risk Analysis and Management ISO14971:2001

For further information about specific training on this subject, please call us on
(+44) (0)845 086 9000 or enter your details in our enquiry form.