January 22, 2026

Understanding the Critical Difference Between Software Lifecycle and Product Validation

As Software as a Medical Device (SaMD) continues to dominate digital health innovation, regulatory scrutiny on software development and validation has intensified. One of the most common and costly regulatory mistakes in SaMD submissions is misunderstanding the difference between IEC 62304 and IEC 82304-1.

At Maven Regulatory Solutions, we frequently see delayed approvals, additional questions, and even non-conformities arising from incorrect application of these two standards.

This guide clearly explains IEC 62304 vs IEC 82304-1, when each applies, and how they work together to meet global regulatory expectations in 2025–2026.

Why IEC 62304 vs IEC 82304-1 Matters in 2026

Global regulators including FDA, EU Notified Bodies, MHRA, TGA, and SFDA now expect clear separation between software verification and product validation, especially for standalone software.

Key drivers in 2026:

  • Increased SaMD approvals and post-market surveillance
  • Stronger focus on usability engineering and real-world use
  • Alignment with ISO 13485, ISO 14971, and IEC 62366-1
  • Rising cybersecurity and lifecycle management expectations

Failing to apply the correct standard at the correct level can result in:

  • Regulatory questions or refusal to accept submissions
  • Gaps in validation evidence
  • Delays in CE marking or FDA clearance

IEC 62304 Explained: The Software Lifecycle Standard

IEC 62304 = “The Engine” (How the Software Is Built)

IEC 62304 defines how medical software is developed, maintained, and controlled throughout its lifecycle.

Scope of IEC 62304

  • Embedded medical software
  • Standalone medical software
  • SaMD components
  • Software within hardware medical devices

What IEC 62304 Covers

  • Software development planning
  • Software architecture and design
  • Coding and unit testing
  • Software risk management (linked to ISO 14971)
  • Software verification and maintenance

Regulatory Goal

Verification
“Did we build the software correctly?”

IEC 82304-1 Explained: The Health Software Product Standard

IEC 82304-1 = “The Car” (The Finished Product)

IEC 82304-1 focuses on the overall health software product, not just the code.

Scope of IEC 82304-1

  • Standalone health software
  • Software as a Medical Device (SaMD)
  • Mobile medical applications
  • Cloud-based diagnostic or monitoring software

What IEC 82304-1 Covers

  • System-level requirements
  • Intended use and clinical purpose
  • Usability and user interaction
  • Labeling, IFU, and user manuals
  • Safety, effectiveness, and performance validation

Regulatory Goal

Validation
 “Did we build the right product for the intended user?”

IEC 62304 vs IEC 82304-1: Side-by-Side Comparison

Aspect

IEC 62304

IEC 82304-1

Focus

Software lifecycle process

Health software product

Level

Code and development

System and user level

Key Objective

Verification

Validation

Applies To

All medical software

Standalone software / SaMD

Covers Labeling & IFU

 No

 Yes

Covers Usability

 No

 Yes

Regulatory Expectation

Mandatory

Mandatory for SaMD

When Do You Need IEC 62304 Only?

Example: Embedded Software

  • Ventilators
  • Infusion pumps
  • Imaging systems

In these cases:

  • IEC 62304 covers software lifecycle
  • Hardware and system validation are addressed via device-level standards
  • IEC 82304-1 is not required

When Do You Need BOTH Standards?

Example: Standalone Software / SaMD

  • Diagnostic mobile apps
  • AI-based clinical decision support software
  • Cloud-based patient monitoring platforms

For SaMD:

  • IEC 62304 ensures the software code is safe
  • IEC 82304-1 ensures the product is usable, validated, and fit for purposes.

Skipping IEC 82304-1 creates a validation gap, which regulators consistently flag.

How Regulators Assess IEC 62304 and 82304-1 in 2026

Regulatory Area

Expectation

FDA

Lifecycle + system validation evidence

EU MDR

SaMD validation and usability proof

UK MHRA

Standalone software safety & performance

Global

Traceability from code → user outcome

Common Compliance Mistakes to Avoid

  • Treating IEC 62304 as sufficient for SaMD
  • Missing usability validation and labeling controls
  • Poor traceability between software risks and user risks
  • Incomplete validation rationale in regulatory submissions

How Maven Regulatory Solutions Supports SaMD Compliance

Maven Regulatory Solutions helps organizations:

  • Map IEC 62304 and IEC 82304-1 requirements correctly
  • Build compliant SaMD documentation packages
  • Align software lifecycle with regulatory strategy
  • Prepare audit-ready verification and validation evidence

Frequently Asked Questions (FAQs)

Is IEC 82304-1 mandatory for SaMD?
Yes. Regulators expect system-level validation beyond code verification.

Can IEC 62304 replace IEC 82304-1?
No. They address different regulatory objectives.

Does IEC 82304-1 include cybersecurity?
Yes, at the product and user-risk level.

Do AI-based SaMD require both standards?
Yes, along with additional AI governance considerations.

Conclusion

Understanding the difference between IEC 62304 and IEC 82304-1 is essential for successful SaMD approvals in 2026. One ensures your software is built correctly; the other ensures your product works safely for real users.

For standalone software, both standards are not optional, they are complementary and mandatory.