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ISO 13485 - The new revision

ISO 13485 represents requirements for a comprehensive management system for the design and manufacture of medical devices. Adopting ISO 13485 provides a practical foundation for manufacturers to address the medical device directives, regulations and responsibilities as well as demonstrating a commitment to the safety and quality of medical devices.

The Revision of ISO 13485 is currently at the Second draft stage, this webinar will talk through the current status of the revision and how the standard will proceed. The content of this revision continues to be structured around the requirements detailed in the Design Specification. This includes the format, which, will be based on ISO 9001:2008. There is no plan, as part of this current revision, to align with the High Level Structure contained in Annex SL as applied in the new ISO 9001:2015.

This revision has also been drafted recognizing that it will have to support the existing European Medical Devices Directives and the proposed European Medical Device Regulations when they are published in the future. Some of the content has therefore been specifically drafted to accommodate this requirement.


Paul Sim - Joining BSI in August 2010 leading the BSI effort working with the Saudi Food & Drug Authority on the implementation of the SFDA Medical Device Interim Regulations. Previously he held senior RAQA leadership positions at Spacelabs Healthcare, Teleflex Medical, Smiths Medical, Ohmeda (formerly The BOC Group healthcare business).