Unannounced audits - supporting Senior Management Executives

CE Marking Medical Devices – European Commission Recommendation of 24 September 2013 (2013/473/EU)

You will be aware that in September 2013 the European Commission published the Recommendation on the audits and assessments performed by Notified Bodies in the field of medical devices, as part of the implementation of the post PIP Immediate Action Measures.

To read the full recommendation, please download the EU Commission Recommendation of 24 September 2013.

Senior Management Executive Letter

Please download a copy of a letter suitable for Senior Management Executives from BSI Global Medical Device Director, Mr Gary Slack.

This has been provided in order to ensure that senior management is aware of the requirements of this recommendation and the associated responsibilities, and can ensure continuing regulatory compliance for your devices.

Senior Management Executives can now receive key priority updates from BSI

As a Senior Management Executive, why not receive key priority updates from us by entering your details below ensuring that all items marked with an asterisk * are completed. 

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