This thread is for discussing the lifecycle document "Electrical safety and EMC tests passed: gate review pack".
The review that confirms type testing for basic safety and essential performance to IEC 60601-1 and its applicable collateral and particular standards, and electromagnetic compatibility to IEC 60601-1-2, is complete, with reports issued, essential performance shown and any failures resolved and retested. For compliance and EMC engineers, verification leads, regulatory affairs and risk management.
Read the document: https://www.thesemiconhub.com/lifecycle/medical/gates/med-safety-tests-passed/document
Point out anything that is wrong, unclear or missing, and say which section you mean. Reviewers read this thread when they audit the document.