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ISO 13485 Regulation Update for Medical Devices: How does it impact you?

SpecialChem / Eamonn Hoxey – Nov 25, 2016

ISO Regulation Update for Medical DevicesISO 13485, Medical devices — Quality management systems — Requirements for regulatory purposes, is a key standard for organizations that need to meet regulatory requirements applicable to the supply chain or life cycle of a medical device.

The third edition of ISO 13485 was published this year, replacing the second edition from 2003. It aims at its utilization by the organizations.

The changes and updates made in the edition have an impact on both the manufactures and the suppliers (materials, coatings…). These updates are important to understand in order to be prepared for discussions with their customers on any changing expectations.

Read more and find out the current regulatory expectations and foreseen future regulatory requirements for medical devices...

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