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ISO 13485

What is ISO 13485

ISO 13485 specifies requirements for a quality management system where an organisation needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.

The primary objective of ISO 13485:2016+A11:2021 is to facilitate harmonised medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements.

The benefits of the ISO 13485 include:

  • Increased access to worldwide markets.
  • Increased organisational efficiency.
  • Increased competence and industry awareness.
  • Adopt a systematic approach to meeting the regulations as well as customer expectations.
  • Comply with regulatory requirements.
  • Providing safe and effective products.
  • Effectively manage risks.
ISO 13485
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