Conducting ISO 13485 audits

Challenge

A blue-chip healthcare consumer products company needed a medical device consultant to conduct an ISO 13485 audit of the mainland Europe manufacturing site of a potential supplier company.

ISO 13485 is an International Organization for Standardization (ISO) standard, published in 2003, which sets out the regulatory requirements for a comprehensive quality management system for the design and manufacture of medical devices.

Our client wanted to assess the capabilities of the supplier to manufacture a novel medical device that was to be marketed under the umbrella of a major household brand. The importance of the brand to our client meant that no risks could be taken with their medical device supply chain.

Solution

Our medical device consultant carried out an in-depth review of the supplier capabilities including an audit of their ISO 13485 quality system, a review of pre-existing medical device technical files, and also provided an expert view of the potential supplier’s technical capabilities with respect to manufacturing the product.

Our ISO 13485 auditor quickly decided on the suitability of the medical device supplier, completing the audit and reporting the findings within three days.

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