FDA submissions, IEC 62304 lifecycle compliance, software audits, and remediation.
Current capabilitySecurity risk assessments, threat modeling, SBOMs, testing, and FDA readiness.
Explore capability ↗Embedded software development, system architecture, debugging, and verification.
Explore capability ↗Ongoing, engineering-led cybersecurity oversight across the medical device lifecycle.
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Software regulatory work should reflect how the device is designed, developed, tested, and maintained. InnoRevision works with medical device teams to assess lifecycle practices, prepare defensible technical documentation, address gaps, and support FDA and EU regulatory reviews with engineering-grounded evidence aligned with current guidance, applicable regulations, and recognized standards.
Development plans, software safety classification, lifecycle procedures, configuration management, change control, and maintenance processes aligned with IEC 62304, applicable QMSR and ISO 13485 processes, and the needs of the product and organization.
Preparation and review of software descriptions, architecture, requirements, risk-related documentation, verification summaries, and traceability aligned with current FDA software guidance and, where applicable, EU MDR technical documentation requirements.
Focused assessments of software procedures, records, development practices, and deliverables against applicable regulatory expectations and adopted standards.
Technical analysis and targeted updates to close documentation and process gaps, resolve FDA questions, and align supporting evidence with actual product behavior.
Coordination of software requirements, architecture, verification, and software-related hazards with the risk management process so claims are supported by objective evidence.
Practical assessments and documentation strategies for existing or inherited systems, including change impact, maintenance, and proportionate lifecycle improvements.
Whether you have a specific software, regulatory, or cybersecurity need—or would like ongoing product security support—we would welcome the opportunity to discuss how InnoRevision can help.
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