This document discusses how static analysis and the MISRA coding standards can help medical device companies comply with FDA guidelines for software development. It provides an overview of the FDA's guidance on software validation and defect prevention. The document argues that MISRA is a good option for medical software because it provides well-defined, auditable coding standards and a process for justifying and documenting deviations. Adopting MISRA allows companies to leverage its proven standards and traceability features to facilitate FDA compliance and software quality.

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2014-10-09
Static Analysis and
the FDA Guidance for
Medical Device Software
Investigating the Application of MISRA
Jason Schadewald, Product Manager

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About Parasoft
World Renowned for Automated Defect Prevention
27 Yrs Founded in 1987
Highly
Focused
Privately held
No debt, No VCs
>2,500 Customers worldwide
27
Years of profitable growth
Years of innovation and customer value
Patents associated with software quality28

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FDA Compliance
 General Principles of Software Validation;
Guidance for Industry and FDA Staff
 http://www.fda.gov/RegulatoryInformation/Guida
nces/ucm126954.htm
 8% of medical device recalls due to software
failures
 80% caused by defects introduced following
changes
 Compliance with FDA becoming increasingly
rigorous

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FDA Software Development Guidelines
FDA guidelines cover well understood software development best practices
FDA guidelines define principles and practices that should be performed but not specific
requirements
• FDA defines ‘what’ not ‘how’
• “Least burdensome approach”
Processes are defined by the Company and must follow the guidelines
• Every company has it’s own defined processes
FDA Approves process and Audits compliance to process
• Process cannot change (without re-approval by the FDA)
Archived reports for future Audits are critical

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Core FDA Concepts
Requirements must be defined
Software Validation and Defect Prevention
Traceability
• from Requirements to Tests
• from Requirements to Source Code
Defined procedures for validation of definitions
• Requirements, Design and Test
Procedure for managing the project lifecycle

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FDA on Static Analysis
3.1.2 “Software testing is one of many verification
activities intended to confirm that software
development output meets its input requirements.
Other verification activities include various static
and dynamic analyses, code and document
inspections, walkthroughs, and other techniques.”
5.2.4 “Source code should be evaluated to verify its
compliance with specified coding guidelines.”

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MISRA
Mission Statement:
“To provide assistance to the automotive industry
in the application and creation within vehicle
systems of safe and reliable software.”

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Why MISRA for Medical?
 Coding Standards
 Well-defined
 Updated
 Flexible
 Deviation Strategy
 Auditable
 Why not?

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Valuable MISRA Features
Accounting for language
versions (C90 vs C99)
Directives and Rules classification
Decidability and Scope
Mandatory, Required, and
Advisory categories

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Deviate Responsibly
“A Specific Deviation is used when a MISRA C guideline is deviated for
a single instance in a single file.” – Section 5.4
 Which guideline
 Scope
 Justification
 Safety assurance
 Consequences and
Mitigations

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Deviations Done Right
Rule 16.3 - “An unconditional break statement shall terminate every switch clause”
Guideline deviated
Scope Justification and
Safety Assurance
Consequences, Mitigations,
Additional Details

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FDA/MISRA Alignment
FDA Guideline MISRA Capability
“Least burdensome approach” Lightweight and flexible
Company defines standards Proven standards pre-packaged
Work must be traceable Provides traceability methodology
Process must be auditable Defines auditable reports

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Other Standards
DIY DO-178 IEC 62304
Effective C++ CWE