December 04, 2025

A Step-by-Step Guide for Ensuring Medical Device Software Compliance with IEC 62304

You’ve spent months building your medical device software, hiring top engineering talent, and ensuring product innovation. Then comes the regulatory review, and you realize your IEC 62304 documentation is incomplete.

Sound familiar? You’re not alone.

Across the medical device industry, countless companies face delays, audit failures, and costly rework because they treat IEC 62304 compliance as just another paperwork requirement — instead of a software safety and quality framework.

The result?

  •  Regulatory rejections
  •  Delayed approvals
  •  Compromised patient safety

In this detailed guide, we’ll simplify IEC 62304 for you — what it means, how to comply, and the processes you must follow to ensure your software is safe, effective, and globally compliant.

What is IEC 62304 and Why It Matters for Medical Device Software

IEC 62304 is the international standard governing the software lifecycle for medical devices, recognized by global regulators including the US FDA, EU MDR, and MHRA.

It defines a structured process for developing and maintaining safe and reliable medical device software, whether your software is:

  • Software as a Medical Device (SaMD)
  • Software in a Medical Device (SiMD)
  • Software used in medical manufacturing or testing

In short — if your software impacts patient outcomes or device performance, IEC 62304 compliance is non-negotiable.

Why IEC 62304 Compliance Is Critical in 2025

  • Mandatory for FDA clearance and CE marking under EU MDR
  • Ensures risk-based development and testing
  • Provides globally harmonized documentation standards
  • Demonstrates regulatory diligence and patient safety
  • Accelerates market approval through structured processes

At Maven Regulatory Solutions, we’ve observed that companies integrating IEC 62304 early in development reduce submission time by up to 6 months and achieve first-time-right approvals.

Understanding IEC 62304 Software Safety Classifications

Before implementation, classify your software risk correctly — this determines your compliance depth.

Class A (Low Risk)

No risk of injury or harm.
Minimal documentation and testing.
Example: Appointment scheduling tool.

Class B (Moderate Risk)

Non-serious injury possible.
Requires unit testing and verification.
Example: Monitoring app with backup systems.

Class C (High Risk)

Potential for death or serious injury.
Requires full documentation, design, and verification.
Example: Insulin delivery or ventilator software.

Remember: Classification is based on potential harm if the software fails, not just its function.

The 5 Core IEC 62304 Processes You Must Implement

Software Development Planning (Clause 5.1)

Define the lifecycle, responsibilities, and tools early.
Create a documented plan linking every phase to your QMS.

Software Requirements Analysis (Clause 5.2)

Ensure each requirement is verifiable.
 Pro tip: If it can’t be tested, it’s not a requirement.

Software Architecture & Design (Clauses 5.3–5.4)

Include:

  • Software architecture diagram
  • Interface specifications
  • Segregation strategies for risk control

If you can’t explain your software architecture to a regulator in 10 minutes — simplify and document better.

Implementation & Testing (Clauses 5.5–5.7)

Perform:

  • Unit, integration, and system testing
  • Acceptance testing

Focus on risk-based testing aligned with safety goals, not just test volume.

Risk Management Integration (Clause 7)

Risk management isn’t separate — it’s continuous.
 Trace each hazard through its lifecycle with control measures and verification.

Navigating SOUP (Software of Unknown Provenance)

Third-party components (OS, APIs, libraries, databases) are called SOUP under IEC 62304.
 Examples: Linux, MySQL, AWS, Android, Azure, Cryptography modules.

SOUP Compliance Checklist:

  • Document name, version, and source
  • Identify risks & anomalies
  • Validate fitness for intended use
  • Implement watchdogs or health checks

SOUP risk management prevents uncontrolled failures and ensures traceability.

IEC 62304 + ISO 14971: Integrated Risk Management

IEC 62304 complements ISO 14971 by extending it to software-specific risks.

Integration Steps:

  1. Conduct system-level hazard analysis under ISO 14971.
  2. Identify software-related causes.
  3. Apply IEC 62304 risk controls and verify their effectiveness.

While ISO 14971 evaluates probability, IEC 62304 assumes 100% failure and focuses on impact.

Common Pitfalls in IEC 62304 Compliance (and How to Avoid Them)

Pitfall

Mistake

Impact

Solution

1. Misclassification

Wrong safety class

Over/under documentation

Perform early risk-based analysis

2. Poor SOUP Management

Ignoring third-party risks

Audit findings

Maintain full SOUP inventory

3. Weak QMS Integration

Treating IEC 62304 as standalone

Compliance gaps

Integrate with ISO 13485

4. Insufficient Change Control

Untracked updates

New risks

Enforce configuration management

5. Documentation Overload

Irrelevant paperwork

Delays

Focus on actionable documentation

IEC 62304 Compliance Checklist

  • Software safety classification documented
  • ISO 13485-aligned QMS in place
  • ISO 14971-based risk management plan
  • Software development plan approved
  • Requirements traced to verification
  • Architecture & detailed design reviewed
  • Unit, integration & system testing completed
  • Maintenance & change control processes defined
  • SOUP inventory & validation documented
  • Post-market surveillance plan implemented

Best Practices for Sustained IEC 62304 Compliance

  • Begin compliance at project planning stage
  • Use digital tools for traceability, testing, and version control
  • Train cross-functional teams (QA, Dev, PM, Regulatory)
  • Plan for software updates and cybersecurity patches
  • Conduct internal audits regularly to prevent findings

Maven Regulatory Solutions: Your Partner for Smart IEC 62304 Compliance

At Maven Regulatory Solutions, we help medical device manufacturers simplify compliance through:

  • Gap analysis & documentation support
  • Software lifecycle & validation strategy
  • Integration of ISO 13485, ISO 14971 & IEC 62304
  • SOUP management and verification assistance
  • Risk-based testing and submission readiness

Our experts ensure your software meets global medical device regulations — from the US FDA and EU MDR to TGA and Health Canada — ensuring first-time-right submissions and faster market approvals.

Conclusion: Compliance is Not Paperwork — It’s Product Confidence

IEC 62304 isn’t just a checklist — it’s your blueprint for safe, reliable, and audit-ready software.

When implemented right, it minimizes risks, accelerates approvals, and builds trust with regulators and patients alike.

At Maven Regulatory Solutions, we make complex compliance simple, helping you build safer products that make a real difference in patient lives.