![]() ![]() Harm and probability of occurrence (para. The manufacturer defines framework criteria for risk acceptability in the form of estimated usage, severity of Process of the medical device, and intends to ensure highest levels of medical device safety consistent with It applies to all people and activities involved in the design, development and distribution The following policy establishes criteria for risk acceptability following ISO 14971:2019 and ISO/TRĢ4971:2020. ![]() Risk Management Activities are integrated in the software development lifecycle as described in SOP Integrated Relevant Processes 1.1 Risk Management Process and Activities ![]() (Records of competence are kept as Part of QMS)ġ. Mapping of Standard Requirements to Document Sections ISO 14971:2019 Section Part of the integrated software development process (SOP Integrated Software Development). References relevant processes and activities which will be conducted for product-specific risk management as The Risk Management Plan contains the risk policy and defines the criteria for risk acceptance. Berlin Competent Authority (LaGeSo), 06/2022 Risk Management Plan ![]()
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