New ISO 13485:2016 standard is now published


New ISO 13485:2016 standard is now published

The new edition of ISO 13485, the internationally recognized quality management systems standard for the medical device industry, is now published.

The new standard provides an effective and comprehensive approach to compliance with the global requirements for a medical device quality management system. The new standard will help manufacturers and service providers comply with medical devices regulation.

The new edition of the standard provides indications for Quality system process management across the entire lifecycle of medical devices. It helps companies maintain conformity and efficiency of the processes affecting the safety and intended use of medical devices: design, development, production, installation, delivery, and any other process related to product quality and safety.

Some of the relevant changes to ISO 13485 include:

  • Standard alignment to global regulatory requirements
  • Additional requirements for design activities, especially validation and verification
  • Additional requirements for supplier control processes, such as risk evaluation
  • Risk management and risk based decision making throughout the quality management system
  • More attention to feedback processes (complaints handling, information from the market)
  • Additional  requirements for software validation, when the software is used in Quality System processes

Merc can help your company implement a Quality System in compliance with the new ISO 13485:2016 Standard, or upgrade your Quality System.

Please contact us for further information