BS EN ISO 13485:2016+A11:2021

What is ISO 13485 - Medical device quality management systems about?

ISO 13485 is an international standard that sets out regulatory requirements for medical device quality management systems. ISO 13485:2016+A11:2021 is the 2021 amendment to the standard which comprises new annexes showing the relationship between the clauses of the standard and the requirements of the European medical devices regulations and IVD medical devices regulation.

Who is ISO 13485 - Medical device quality management systems for?

ISO 13485 on medical device quality management systems can be adopted by the following:

• Medical device manufacturers and other organizations in the supply chain for medical devices including authorized representatives, importers, and distributors
• Conformity assessment bodies

What does ISO 13485 - Medical device quality management systems cover?

ISO 13485 gives regulatory requirements for medical device quality management systems. It provides the basis for ensuring consistent design, development, production, installation, and delivery of products that are safe for their intended purpose. It also harmonizes global requirements and is recognized by regulators in many jurisdictions around the world.

ISO 13485 was last revised in 2016 and in 2021 was confirmed for a further 5 years.

Why should you use ISO 13485 - Medical device quality management systems?

• ISO 13485 can help you implement an effective medical device quality management system that consistently produces safe and effective medical devices
• It can help you demonstrate conformity with regulatory requirements
• ISO 13485 further harmonizes regulatory requirements between different jurisdictions and thereby decreases the number of unique requirements for individual markets
• The new annexes enable manufacturers and notified bodies to conduct a gap analysis to identify where attention is needed to supplement the standard to meet new European requirements
• ISO 13485 enables users to develop their expertise with a medical device quality management system and with regulatory compliance
• It’s an effective way to manage risk and improve processes and efficiency
• Ultimately, its use can increase trust in your medical devices and thereby confer some competitive advantage 

What’s new about ISO 13485 - Medical device quality management systems?

This is an amendment to ISO 13485 which adds annexes mapping the requirements of the European MDR and IVDR against the requirements for quality management systems within each of the regulations. Each regulation has its own annex. Each annex contains three tables. These three tables map out the relationship of the standard with requirements in the regulation on:

• The general obligations of the manufacturer in Article 10
• The quality management system requirements in Annex IX on conformity assessment based on a quality management system and on assessment of technical documentation
• The quality management system requirements in Annex XI on conformity assessment based on product conformity verification

ISO 13485 contributes to UN Sustainable Development Goal 3 on ensuring healthy lives and promoting well-being for all of all ages.

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