ISO 62304 Software Lifecycle Assessment

Evaluate medical device software development per ISO 62304:2006/AMD1:2015, covering software safety classification, development processes, risk management, and maintenance

MedtechHealthcareBiotechTechnology25 minutes20 questions

1. Software Safety Classification

Have you classified software safety per ISO 62304 (Class A, B, or C)?*

Clause 4.3: Classification based on harm severity - Class A (no injury), B (non-serious), C (death/serious injury)

Is the software safety classification justified and documented?*

Clause 4.3: Document rationale based on risk analysis (ISO 14971)

Are all software items (SOUP, modules) assigned appropriate safety classes?*

Clause 4.3: Segregate software by safety criticality

2. Software Development Planning

Is a software development plan created per Clause 5?*

Clause 5.1: Plan defines lifecycle model, deliverables, verification, risk management

Does the plan identify standards and tools for development?*

Clause 5.1.4: Programming languages, compilers, CASE tools, coding standards

Is configuration management and version control defined?*

Clause 5.1.5: CM procedures for software items, SOUP, documentation

Are problem resolution and change control processes established?*

Clause 5.1.9: Document process for analyzing and resolving software issues

3. Software Requirements

Are software system requirements defined and traceable to system requirements?*

Clause 5.2: System requirements include functional, performance, interface, security

Are software requirements unambiguous, verifiable, and free of conflicts?*

Clause 5.2.6: Requirements quality ensures testability

Have you implemented risk control measures from ISO 14971 in software requirements?*

Clause 5.2.4: Software requirements address identified hazards

4. Software Architecture & Design

Is a software architecture defined showing major components and interfaces?*

Clause 5.3: Architecture partitions software into items with defined interfaces

Does the architecture segregate safety-critical software from non-critical?*

Clause 5.3.4: Isolation reduces unintended interactions

Is detailed design documented for all software units?*

Clause 5.4: Unit design sufficient for implementation and testing

5. Software Verification & Validation

Do you perform software unit testing per Clause 5.5?*

Clause 5.5: Unit tests verify implementation against detailed design

Is integration testing performed to verify interfaces and data flow?*

Clause 5.6: Integration tests verify software items work together

Is system testing performed to verify software meets requirements?*

Clause 5.7: System tests cover all software requirements

Is software validation performed to confirm user needs are met?*

Clause 5.8: Validation in intended use environment with representative users

6. Software Maintenance & Problem Resolution

Is a software maintenance plan established?*

Clause 6.1: Plan covers monitoring, problem analysis, change implementation

Do you analyze all software problems and implement corrections?*

Clause 6.2.1: Problem reports investigated, root cause determined, corrective action

Are software changes evaluated for impact on safety and re-verification?*

Clause 6.2.2: Regression analysis and re-testing after changes

Please answer all required questions to see your results