June 16th, 2020, The International Organization for Standardization (ISO) published the long-delayed Technical Report 24971, a companion document for the recently updated risk management standard ISO 14971.
ISO/TR 24971:2020 provides guidance on the development, implementation and maintenance of a risk management system for medical devices according to ISO 14971:2019. The clauses and subclauses in the technical report have the same structure and numbering as the clauses and subclauses of ISO 14971:2019. The revised technical report also includes eight annexes that contain additional guidance on specific aspects of risk management, including the identification of hazards, risk analysis techniques and risk acceptability considerations, as well as guidance for firms that make in vitro diagnostics.
What does this mean to you?
With the release of this technical report you now have all the information you may need to implement the updated risk management standard and to achieve compliance.
Should you want to discuss this more in depth with one of our consultants, please do not hesitate to get in touch with us.
