ISO 13485 is the globally recognised standard for medical device quality management.

Published February 25, 2016, ISO 13485:2016 focuses on quality management systems and is recognised and used as a framework by the medical device industry regulators programs, including the Medical Device Single Audit Program (MDSAP).

The ISO 13485 standard provides manufacturers, designers, and suppliers to the medical device industry with a framework necessary to demonstrate compliance to regulatory requirements and mitigate risks to stakeholders. It places more emphasis on risk-based thinking and decision-making while it also offers stronger intra-operability between the clauses and requirements.

Perhaps most importantly, it focuses on ensuring consistent quality, product safety and the sustainable success of your products or services, using competent and efficient quality management systems to support them. Persistent pressures from global competition demand that organisations continually improve your products, services, and business processes to remain competitive.

Key elements of the ISO 13485:2016 standard include

  • Expands requirements for risk management and process-based decision-making.
  • Increased attention on supply chain processes.
  • Explicit requirements for software validation.
  • Effective alignment of global regulatory requirements.

Partner with Intertek and gain the confidence of knowing you have a solid Quality Management System in place for medical devices.

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SAI Global Standards is an Intertek company - Access and purchase ISO 13485 standard in a format that suits your needs.

Intertek Business Assurance does not provide consulting services for management systems certification. Any consulting activities provided by Intertek are separated and independent from testing and certification activities and undergo a regular detailed risk analysis to ensure impartiality is maintained.

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