What Is IEC 62304 Compliance and Why It Matters for Medical Software

Software now powers everything from infusion pumps to remote diagnostics but with innovation comes regulatory scrutiny. Analyses of FDA data show that roughly one-fifth of recalls were software-related (19.4% in 2005–2011), and 627 devices were recalled for software defects between 2011–2015—evidence that safer medical software depends on disciplined process, not heroics. SaMD  (Software as a Medical Device) is growing fast, and regulators are watching.

That discipline is exactly what IEC 62304 compliance provides: a structured software lifecycle for medical device software designed to align with ISO 13485 (Software as a Medical Device) 5 quality systems and ISO 14971 risk management for SaMD. If you build software that touches patient care, IEC 62304 is the playbook for auditable safety and regulator confidence. 

What Is IEC 62304 and Why Does It Matter for Medical Software?

The IEC 62304 standard defines the software lifecycle processes required to design, develop, maintain, and validate medical device software. Established by the International Electrotechnical Commission (IEC), it provides a unified global framework that aligns with ISO 13485 quality management and ISO 14971 risk management practices. In essence, it ensures that every line of code in a SaMD product is developed under the same rigor as its physical hardware.

According to the FDA’s Digital Health Center of Excellence, over 70% of new medical devices contain embedded or standalone software, making IEC 62304 compliance a baseline expectation for market approval in both the U.S. and EU. Without this framework, software-driven devices risk failing regulatory audits or post-market surveillance due to unverified code or missing validation evidence.

The importance of IEC 62304 compliance in healthcare extends beyond documentation. It creates traceability between software requirements, design, implementation, and verification of a chain that regulators can audit to confirm safety and reliability. This lifecycle approach helps developers detect risks early, enforce version control, and integrate continuous validation practices into their CI/CD pipelines. As healthcare software systems grow more complex, compliance with IEC 62304 ensures these systems meet international safety standards while staying innovation-ready.
 

What Types of Software Need IEC 62304 Certification?

The IEC 62304 standard applies to any medical software that can influence patient diagnosis, treatment, or safety, whether embedded in a device or operating independently as SaMD (Software as a Medical Device). This includes everything from a pacemaker’s firmware (Software in a Medical Device, or SiMD) to an AI-based radiology diagnostic app running on a hospital cloud (SaMD). Even non-clinical systems, such as connected monitoring dashboards or telehealth modules, may fall under IEC 62304 compliance in healthcare if they interact with regulated data or device functions.

Recent market data underscores how widespread software dependency has become: nearly 80% of new medical devices now contain software components, and the global SaMD market is projected to exceed $86 billion by 2027, growing at over 22% annually. This growth brings new regulatory attention especially from the FDA, EMA, and MHRA, which all reference IEC 62304 in their medical device software guidance as a benchmark for safety and lifecycle management.

To simplify classification, IEC 62304 distinguishes between three main categories of medical software systems:

Understanding which category your product fits into determines the documentation depth and testing rigor required for IEC 62304 certification, as each class carries a different level of regulatory responsibility and validation scope.

What Are the Core Requirements of IEC 62304 Compliance?

The IEC 62304 standard defines a structured framework of five lifecycle processes that govern the safe design, development, and maintenance of medical device software. These processes ensure traceability, documentation, and risk management across every stage of the software lifecycle. Each process must align with the organization’s ISO 13485 quality management system and ISO 14971 risk management framework, ensuring that compliance is built into both technical and organizational workflows.

At its core, IEC 62304 compliance in healthcare covers:

1. Software Development Process – Planning, requirement analysis, architectural design, implementation, integration, and verification.
   
   

2. Software Maintenance Process – Managing updates, patches, and error corrections under controlled documentation.
   
   

3. Software Risk Management Process – Identifying hazards and linking each risk to mitigations, in alignment with ISO 14971.
   
   

4. Software Configuration Management – Version control, change management, and release tracking.
   
   

5. Problem Resolution Process – A structured method to document, analyze, and resolve field issues or defects.
   
   

How Does IEC 62304 Classify Software Safety (A, B, and C)?

One of the most critical aspects of IEC 62304 compliance is the software safety classification system: a structured method to categorize risk based on the potential impact of software failure on patient safety. The standard defines three distinct safety classes: Class A, Class B, and Class C, each dictating the depth of validation, documentation, and testing required. This ensures that the software lifecycle process scales in proportion to clinical risk, keeping regulatory expectations transparent and measurable.

In 2023 alone, the European Medicines Agency (EMA) recorded over 150 SaMD recalls linked to improper safety classification or incomplete verification documentation. Properly implementing IEC 62304 software safety classification helps prevent such costly errors and enables developers to align design, testing, and risk controls with ISO 14971 and FDA 21 CFR Part 820 requirements from the start.

What Documentation Is Required for IEC 62304 Compliance?

Complying with IEC 62304 requires detailed and traceable documentation across every phase of the software lifecycle. These documents collectively demonstrate that your medical device software is safe, verified, and aligned with ISO 13485 and ISO 14971 frameworks. Auditors from the FDA, Notified Bodies, or MDR authorities rely on these records to confirm that the development process meets international safety and performance expectations.

The core documentation set for IEC 62304 compliance in healthcare includes:

1. Software Development Plan (SDP): Defines project scope, roles, responsibilities, and lifecycle model.
   
   

2. Software Requirements Specification (SRS): Lists all functional and non-functional requirements with traceability links.
   
   

3. Software Architecture and Design (SAD): Outlines system components, data flow, and control logic.
   
   

4. Verification and Validation (V&V) Reports: Demonstrates testing coverage, results, and evidence of conformity.
   
   

5. Risk Management File (RMF): Integrates hazard analysis and mitigations aligned with ISO 14971.
   
   

6. Traceability Matrix: Maps requirements to implementation, testing, and validation results.
   
   

7. Configuration and Maintenance Records: Captures versioning, updates, and release history.
   
   

How Does IEC 62304 Integrate with Other Standards (ISO 13485, ISO 14971, IEC 82304)?

The strength of IEC 62304 compliance lies in how it integrates with other cornerstone standards of medical device software regulation. It doesn’t function in isolation. It complements frameworks like ISO 13485, ISO 14971, IEC 82304, and IEC 62366 to create a complete, traceable quality ecosystem. This interconnected approach ensures that every phase of the software lifecycle, from design inputs to post-market surveillance, is measurable, verifiable, and compliant with both FDA and EU MDR expectations.

At a high level:

• ISO 13485 governs quality management systems (QMS), ensuring that the development environment itself meets regulatory consistency.
  
  

• ISO 14971 defines how to manage and document risk management throughout the lifecycle.
  
  

• IEC 82304-1 applies to health software not classified as a medical device but still impacting patient outcomes (e.g., wellness apps, telehealth tools).
  
  

• IEC 62366 addresses usability engineering, ensuring safe and intuitive interfaces for clinical users.

When implemented together, these frameworks create a unified compliance backbone where every design change, software update, or risk control is supported by audit-ready evidence.

Common Challenges in Achieving IEC 62304 Compliance (and How to Overcome Them)

• Documentation depth and traceability gaps: Teams new to IEC 62304 compliance often under-document the software lifecycle which slows audits and market access.

Fix: Establish a living traceability matrix, gated reviews, and evidence checklists mapped to ISO 13485/ISO 14971 from day one.

• Misclassifying software safety class (A/B/C): Wrongly classing SaMD as Class A (when it should be B/C) leads to under-testing; over-classing bloats V&V.

Fix: Do early hazard analysis using ISO 14971, align with MDCG 2019-11 and the FDA’s SaMD risk logic, and re-confirm the class at each major release.

• Manual, spreadsheet-driven compliance: Version conflicts and missing review logs are common when medical device software evidence is tracked manually.

Fix: Use a QMS-integrated system (e.g., eQMS) for configuration management, approvals, and audit trails; connect requirements, code, tests, and risks.

• Treating 62304 as a “one-time” certification: Compliance erodes if maintenance, problem resolution, and post-market changes aren’t run under the same IEC 62304 controls.

Fix: Operate change control, regression testing, and impact assessments for every update; keep V&V and risk management continuous.

• Under-resourced verification & validation (V&V): Inadequate unit/integration/system testing weakens evidence, especially for Class B/Class C software.

Fix: Plan risk-proportional V&V (coverage goals, independence of testing, negative paths), and automate evidence capture in CI/CD.

• Weak configuration and release control: Missing baselines, unclear software of unknown provenance (SOUP), and ad-hoc hotfixes break audit trails.

Fix: Enforce software configuration management with labeled baselines, SOUP assessment, reproducible builds, and signed release notes.

Next Steps for Healthcare Innovators

For MedTech founders, CTOs, and regulatory leads, achieving IEC 62304 compliance is not just about documentation but about building a repeatable system for safety, quality, and innovation. Below is a practical roadmap to help healthcare innovators move from awareness to execution:

1. Audit Your Software Lifecycle: Begin with a comprehensive audit of your software development process and documentation. Check for missing artifacts like the Software Development Plan (SDP) or Verification & Validation (V&V) reports required under IEC 62304.
   
   

2. Map Risks Early Using ISO 14971: Conduct a structured risk analysis and assign a software safety class (A, B, or C). Use ISO 14971 to link every hazard to its control measure and test evidence.
   
   

3. Integrate Compliance Into Development: Shift compliance left, embed traceability matrices, version control, and change management directly into your CI/CD pipelines. Automate evidence capture to maintain continuous audit readiness.
   
   

4. Validate and Verify Continuously: Treat verification and validation (V&V) as an ongoing activity, not a final phase. Plan test strategies based on software risk classification, higher-risk systems (Class B/C) require deeper verification.
   
   

5. Measure Compliance KPIs: Track measurable indicators such as requirement coverage ratio, risk closure rate, and audit non-conformity count. These KPIs offer a quantifiable view of software safety and regulatory readiness.
   
   

6. Partner With Compliance-Driven Experts: Collaborate with technology partners who understand both medical software development and regulatory frameworks like ISO 13485, IEC 62304, and EU MDR. 

   
   

Conclusion

As the boundaries between hardware and software continue to blur, IEC 62304 compliance stands as the backbone of modern medical device software safety. It transforms development from a reactive, document-driven process into a proactive, traceable system built on risk management, verification, and regulatory confidence.

For innovators building SaMD or connected healthcare solutions, this standard provides a framework for accountability, patient safety, and long-term market trust. By embedding IEC 62304 principles into every phase of the software lifecycle, teams can innovate faster without compromising compliance.

At Latent, we help healthcare innovators bring that vision to life by designing, validating, and deploying IEC 62304-ready software systems that meet global regulatory benchmarks. Our expertise bridges product engineering and compliance architecture, ensuring that every line of code aligns with ISO 13485, ISO 14971, and FDA/MDR requirements.