Services
Offering services to medical device companies requiring support in Software Design Control, Risk Analysis, Design & Development Process/Design Verification/Validation, Design History File updates, Compliance and Regulatory services.
Requirements Management
Analyze and document functional and non-functional requirements, produce traceability reports.
Documentation & Compliance
Help with software development plan, configuration management, architecture and design documents, updates to procedures, bill of materials for software releases, and design history files.
Verification & Validation
Review verification, validation procedures, reports, code reviews, static analysis, assist in testing as required.
Configuration Management
Update change request documents, document control systems.
Standards
Provide practical guidance applying and interpreting ISO13485, IEC62304, ISO14971, IEC80001, ISO9001, 21 CFR 820.30.
Risk Management
Conduct software risk management activities using tools such as FMEA and Fault Tree Analysis and threat modeling tools for threat analysis.
Defect Management
Record, evaluate and disposition of defects during test.
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