IEC 62304
Skill packages tagged with “IEC 62304”
IEC 62304 Software Lifecycle Author
Guided elaboration of medical device software lifecycle documentation per IEC 62304 — SDP, SOUP identification, SRS, design, verification/validation, and risk control integration.
MDevSPICE Capability Profile
Draft a capability profile or assessment pack for MDevSPICE; document target capability levels and evidence per process for assessors.
MDevSPICE Process Area Documentation
Document how each MDevSPICE process area is implemented; create evidence for MDevSPICE assessment and auditors.
MDevSPICE Process Coverage
Map organizational processes to the MDevSPICE process reference model and IEC 62304; document process coverage for assessment or audit.
MDevSPICE Regulatory Readiness Narrative
Draft a regulatory readiness narrative for FDA (21 CFR 820), EU MDR, and IEC 62304; document evidence and alignment for audit or submission.
MDevSPICE Software Configuration Management Process
Document and evidence the software configuration management process per IEC 62304 and MDevSPICE: identification, change control, build and release, configuration status accounting.
MDevSPICE Software Development Process
Document and evidence the software development process per IEC 62304 and MDevSPICE: development plan, requirements, design, implementation, verification, integration and system testing, release.
MDevSPICE Software Maintenance Process
Document and evidence the software maintenance process per IEC 62304 and MDevSPICE: maintenance plan, problem and modification analysis, implementation of changes, maintenance release, retirement.
MDevSPICE Software Problem Resolution Process
Document and evidence the software problem resolution process per IEC 62304 and MDevSPICE: problem reporting, analysis, root cause, corrective action, and link to maintenance and CAPA.
MDevSPICE Software Risk Management Process
Document and evidence the software risk management process per IEC 62304 and MDevSPICE: risk management plan, risk analysis, risk control, risk review, production and post-production monitoring.