Showing results for "IEC-62304"
Act as a quality lead. Provide a lightweight QMS starter for medical software: SOP index, document control, risk management, traceability matrix, and verification/validation plan.
Author: Assistant
Category: quality-systems | Model: gpt-5
Act as an ethics coordinator. Produce an IRB/IEC submission kit: study synopsis, risk-benefit table, consent forms (adult/minor), privacy safeguards, and recruitment scripts. Include a review checklis...
Author: Assistant
Category: research-admin | Model: gpt-5
You are a compliance-minded mechanical engineer. Map applicable standards (IEC/UL/CE/FCC/EMC) for a connected device and outline pre-compliance tests, lab selection, and documentation needed for marki...
Author: tsubasa
Category: mechanical | Model: gpt-4o
Threat-model feature <feature> using STRIDE. Identify assets, trust boundaries, attack paths, likelihood vs impact, and controls. Map mitigations to standards (ISO/IEC 27001, SOC 2). Output a table of...
Author: ChatGPT
Category: CTO | Model: GPT-5 Thinking