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ISO 13485:2016 Medical devices

ISO 13485:2016 Medical devices

The international quality management system (QMS) standard for medical devices, ISO 13485:2016 (Medical Devices – Quality management systems – Requirements for regulatory purposes) was published 1 March 2016. This  standard includes the need for a risk-based approach to the QMS, an enhanced focus on regulatory requirements and the responsibilities of top management, increased controls over suppliers and outsourced activities, and an emphasis on risk management throughout the product lifecycle.

ISO 13485 applies to both manufacturers of medical devices and organisations that support medical device manufacturers. It underpins the manufacturers’ duty of ensuring devices consistently meet customer and applicable regulatory requirements.

Benefits of ISO 13485

Key potential benefits from use of the standard include :

  • Legal Compliance
  • Enhanced Risk Management
  • Improved access to information
  • Expand potential market
  • Supports Contracts with larger companies
  • Demonstrates commitment to best practice in quality and patient safety.