February 3, 2026

ISO 13485 for Software Development: How the Standard Applies to Medical Device Software

Medical software has strict quality expectations because it influences diagnosis, monitoring and treatment. ISO 13485 is the quality management system used across the medical industry and it applies directly to software development. Companies building Software as a Medical Device or software that operates inside a device need to follow this standard to support safety and regulatory approval.

This guide explains how ISO 13485 works for software, what the standard requires, how it affects SaMD development and why many teams choose to work with ISO 13485 certified software partners.

Does ISO 13485 Apply to Software Development?

Yes. ISO 13485 applies to any software that performs a medical function. This includes:

• stand alone Software as a Medical Device
• mobile and desktop medical applications
• embedded software inside medical devices
• clinical workflow tools that support diagnosis or monitoring

ISO 13485 defines how a company structures, documents and maintains its development process so that the software remains reliable, safe and fully controlled.

Key ISO 13485 Requirements for Medical Device Software

Companies developing regulated software must follow a structured and traceable lifecycle. The standard includes several core requirements.

• Risk Management: Risks must be identified, analysed and controlled throughout the development process. Records must show how hazards were evaluated and addressed.
• Traceability: Every requirement must link to design decisions, code, tests and validation results. This traceability helps regulators confirm that the software behaves as intended.
• Documentation: ISO 13485 requires a controlled set of documents that cover the entire lifecycle. These include requirement files, design documentation, validation plans, test protocols, test reports and maintenance procedures.
• Verification and Validation: Software must be checked and tested at each stage to confirm that it meets functional and safety requirements. Evidence must be recorded clearly.
• Change Control and Maintenance: Updates and bug fixes must follow a documented process. This ensures that changes do not introduce new risks or break existing behavior.

How ISO 13485 Supports Software as a Medical Device (SaMD)

For SaMD products, the standard helps teams organise:

• intended use definitions
• risk classification
• validation strategy
• evidence for regulatory submissions
• post market updates

Following ISO 13485 helps SaMD developers build the documentation needed for regulatory pathways and reduces delays caused by missing evidence.

Why Companies Work With ISO 13485 Certified Software Partners

Choosing an ISO 13485 certified partner gives companies:

• a structured and proven development process
• predictable documentation for regulatory submissions
• controlled change management
• reduced development risk
• confidence that the software aligns with medical device expectations

For teams without an internal QMS, a certified partner provides a framework that keeps the project aligned with regulatory requirements from the beginning.

How Beriflapp Applies ISO 13485 in Real Projects

Beriflapp is ISO 13485 certified for both stand alone medical software and embedded medical device software. Our quality management system includes:

• structured requirement analysis
• documented risk management
• code reviews and controlled versioning
• detailed test protocols and results
• traceability across the lifecycle

Healthcare organisations use this framework to support their own compliance and to speed up approval processes.

Frequently Asked Questions About ISO 13485 and Software

What is ISO 13485 in software development?
It is a quality management system that controls how medical software is planned, documented, developed, tested and maintained.

Is software covered by ISO 13485?
Yes. The standard applies to both SaMD and embedded medical software.

Why is ISO 13485 important for SaMD?
It provides the documentation and traceability required for regulatory submissions and ensures that the software is developed under controlled conditions.

Do all software companies need ISO 13485?
Only companies working on medical device software or SaMD. For these products, a compliant QMS is essential.

Get Support Developing Software Under ISO 13485

If you are building medical device software or a SaMD product, Beriflapp can support the full development lifecycle under an ISO 13485 certified process. To learn more, contact our team or visit our Services page.