ISO 13485

ISO 13485 is intended for use by organisations that design and / or manufacture and supply medical devices. It is used by organisations that are required to demonstrate compliance to UK and FDA (American) regulatory requirements.

Based on the generic ISO 9001:2000 Quality Management System standard , ISO 13485 specifically addresses the very stringent controls required by the UK and USA (FDA) regulatory authorities, for example sterilisation, labelling, recall etc

Typically an audit, although similar to ISO 9001, is conducted against the requirements of ISO 13485 but has a different focus. The auditors need to be specially trained and qualified and the audits are slightly longer in duration.

CLM has a wealth of experience in medical devices and laboratory assessments .

Contact CLM today to discuss how we can help you implement and maintain the ISO 13485 standard.