Module 19 2021

02/06/2021

Major Changes to 2019 revision

• Introduction of new terms benefit, reasonably foreseeable misuse and state of the art • Focus on benefits and risk-benefit from the use of the device • Inclusion of data and system security within the standard • Requirements for overall residual risk evaluation • Disclosure of residual risk • Requirement for a risk management report to be available before commercial release of a product

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Risk Management within the QMS

• Embedded throughout ISO 13485:2016 • Manufacturers required to show interconnected approach to risk

4.1 General Requirements

7.1 Planning and Product Realization

7.3 Design and Development

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ISO 13485:2016

7.4 Purchasing

7.5 Production and Service Provision

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