New updates in ISO 14971 2019
In medical devices risk management has high importance which necessitated ISO 14971 providing a generic risk-management framework applicable to all medical devices, from design and development through production and post-production activities.
This new edition ISO 14971:2019, consisting of 10 clauses and three annexes (informative), along with an updated companion report, ISO/TR 24971 provides clear guidance and better detail in the application of risk management concepts while aligning with essential safety and performance principles. European directives and regulations do not provide enough guidance on additional steps to take in the risk management process, nor on the acceptability of residual risks, so this standard represents the state of the art.
Topics covered in this Comprehensive Guide include:
- ISO 14971:2019 Annexes compared to ISO 14971:2007
- Specific changes between ISO 14971:2007 and ISO 14971/ TR 24971:2019