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Medical devices: Revised ISO-standard for quality management

Medical devices: Revised ISO-standard for quality management
For the first time in more than 12 years, the international recognized ISO standard for medical devices quality management systems has been revised into a 2016 standard, named ISO 13485:2016.

SO 13485 specifies requirements for a quality management system that can be implemented by medical device companies to help demonstrate regulatory compliance, and the standard is accepted as the basis for CE marking medical devices under EU-directives. The newly revised standard has been prepared by a team of experts from all over the world, including representatives from public authorities.

What is new?

The most significant changes in the revised standard are:

  • Increased requirements in regard of validation and verification;

  • Increased focus on feedback from patient’s experiences with products on the market;

  • Greater emphasis on risk-based decision making; and

  • Strengthening of procedures of supplier control.

Overall, the renewal of ISO 13485 should mean improved safety for patients and less technical obstacles for companies operating across borders.

ISO 13485 will have a transition period of three years from 1 March 2016 entailing that the new standard will be adopted while companies’ current certifications expire.

Delacour recommends

Companies that manufacture or supply medical devices should study the revised ISO-standard and consider contacting a certifier organization to discuss the options for a (re-)certification. Furthermore, companies should consider to conduct an analysis examining areas that are not covered by the 2003-standard and – if relevant - implement the improved processes that cover the gaps identified between the 2003 and 2016-standards.

ISO 13485:2016 is available in English and will be available in Danish within short time.


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