IN-PERSON CSF 2.0 WORKING SESSIONS | February 22 or 23, 2023 (half day events).The Paper will be discussed at the upcoming CSF 2.0 Workshop #2 on Februand the CSF 2.0 Working Sessions on February 22-23, 2023. Please provide feedback by March 3, 2023. NIST has released the “Cybersecurity Framework 2.0 Concept Paper: Potential Significant Updates to the Cybersecurity Framework,” outlining potential significant changes to the Cybersecurity Framework for public review and comment.NIST has released NIST IR 8323 Revision 1 | Foundational PNT Profile: Applying the Cybersecurity Framework for the Responsible Use of PNT Services.Please provide feedback by March 17th, 2023. The comment deadline for the Cybersecurity Framework 2.0 Concept Paper has been extended by two weeks.Intro material for new Framework users to implementation guidance for more advanced Framework users. Informative References Expand or Collapse.Events and Presentations Expand or Collapse.Frequently Asked Questions Expand or Collapse.You can also generate the Risk Management Plan and Risk Management Report automatically from the SoftComply Risk Manager apps. SoftComply Risk Manager and SoftComply Risk Manager Plus provide you with an ISO14971 compliant risk management template in Jira and support the establishment of full traceability between risks, requirements and tests. (16.9.1) Connection terminals and connectors.(15.4.2) Temperature and Overload control.(15.4.1) Interchangeability of connectors.(a very complicated way to state that V&V members and developers must be independent…) (14.11) All professional relationship between the members of the PEMS validation team with the members of the design team.(14.4) Reference to the PEMS Validation plan in the Risk Management Plan.(11.6) Overflow, spillage, leakage, ingress of water or particulate matter, cleaning, disinfection, sterilization and compatibility with substances used with the ME equipment.(11.5) ME equipment and ME systems intended for use in conjunction with flammable agents.(11.2.2) ME equipment and ME systems used in conjunction with oxygen enriched environments.(9.8.3) Strength of Patient or Operator support or suspension systems.(8.4.4.1) Mechanical strength and resistance to heat.In most cases the requirements overlap with ISO 14971, but there are some additions: Remember also that IEC 60601-1 is a good contributor to the Risk Management File. The PMS process itself should then be able to trigger the risk analysis process, as required. A pointer to the PMS plan and procedures will be sufficient. Items 19 and 20 are part of the PMS process.Items 14, 16, 17 can be merged (end generally are) in the Risk Management Review and Report 18.Alternatively, if each mitigation has a corresponding (traceable) requirement, the trace is taken care of by the requirement → verification traces. Item 3 provides links for items 12 and can be built into the risk analysis documents.Items 6 and 9 can be built into the Risk Management Plan 2.Items 4, 5, 7, 8, 10, 11, 13, 15 are generally contained in each single risk analysis document.Items 1 and 5 are typically contained in separate documents in the DHF. This seems a lot, but let’s look into the details of these items: (10.4) Decision arising from the review of post-production information.(10.3) Results of the review of the post-production information.(9) Risk Management Report, including Risk Management Review.(8) Evaluation of Overall Residual Risk. (7.6) Review of completeness of risk controls.(7.5) Risks arising from implemented risk control measures.(7.4) the results of the Benefit-Risk Analysis.(7.2) Verification of Implementation of the Risk Control Measures.(5.5) The system used for qualitative or quantitative categorization of probability of occurrence of harm and severity of harm.(5.4) Hazards, the reasonably foreseeable sequences or combinations of events that can result in a Hazardous Situation, and the resulting hazardous situation(s).Where appropriate, the manufacturer shall define limits of those characteristics. (5.3) Qualitative and quantitative characteristics that could affect the safety of the medical device.(5.2) Intended Use and Reasonably Foreseeable Misuse.
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