Software validation for medical devices following ISO 13485 and ISO 62304
The validation of software development is a central component of regulatory requirements for medical devices. In accordance with ISO 13485 and ISO 62304, it ensures that software functions safely, reliably and in compliance with standards. Whether development validation, installation testing or proof of operation - every form of validation makes a significant contribution to product quality, patient safety and increased efficiency in the development process.
What does ISO 13485 say?
Validation types at a glance
Validation types at a glance
Software validation in accordance with ISO 13485 and ISO 62304 comprises various forms of validation that cover different phases of the software life cycle. Each of these fulfills a specific role for safety, quality and compliance:
Development validation
Ensures that the developed software meets the specified requirements.
- Focus: Functionality & architecture
- Standard reference: ISO 62304 (5.1.4), ISO 13485 (7.3.6)
Installation validation
Checks whether the software is installed and configured correctly - on all target systems.
- Focus: Stability & reproducibility
- Standard reference: ISO 62304 (5.7), ISO 13485 (7.5.1.1)
Operational validation
Ensures that the software works as intended in real-life use.
- Focus: User acceptance & real scenarios
- Reference to standards: ISO 62304 (5.1.8), ISO 13485 (7.3.6)
Performance validation
Checks the performance of the software under regular and extreme conditions.
- Focus: speed, scalability, resilience
- Standard reference: ISO 62304 (5.1.8), ISO 13485 (7.3.6)
Traceability validation
Ensures that all requirements and changes are documented in a traceable manner.
- Focus: Transparency & auditability
- Standard reference: ISO 62304 (5.1.3), ISO 13485 (7.3.2)
Herausforderungen Automotive SPICE und wie sepp.med unterstützt
Herausforderungen Automotive SPICE und wie sepp.med unterstützt
Your advantages at a glance
Validation in accordance with ISO 13485 & 62304 not only provides regulatory security, but also measurable added value for your product development:
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Risk minimization: errors are detected early, safety risks are reduced
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Regulated conformity: compliance with legal and normative requirements
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Quality assurance: Validated software is stable, secure and reliable
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Cost savings: reduction of expensive rework, support cases or recalls
From ISO 13485 to 62304 - we bring clarity to your validation
From ISO 13485 to 62304 - we bring clarity to your validation
The validation of medical software is complex - and many companies lack the time, resources or specific expertise to implement the regulatory requirements efficiently and reliably. The result: uncertainties in the process, a lack of evidence during audits and expensive delays.
Typical challenges on the customer side:
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Lack of clarity about regulatory requirements
Which forms of validation are required and when? Which standards apply to my product? -
Lack of time and resources
Validation is time-consuming - especially with tight timelines and parallel projects. -
Uncertainty about documentation
What evidence do I need to provide and how? How much documentation is "enough"? -
Lack of integration into the development process
Validation is often only considered at a late stage - instead of being integrated from the outset.
Our solution:
We support you from the planning phase through to auditability - with a structured, standard-compliant and pragmatic approach:
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Advice on standards & requirements
We clarify with you which forms of validation are necessary for your product and how to implement them correctly - in relation to ISO 13485 & ISO 62304. -
Process-integrated validation strategy
We help you to integrate validation into your existing processes (e.g. agile development, V-model) early and efficiently - without additional effort. -
Structured documentation & templates
We provide clear checklists and templates with which you can easily create standard-compliant evidence and remain audit-ready at all times. -
Individual workshops & project support
Whether you have individual questions or a complete validation plan - we adapt our approach to your needs and guide you through the process in a targeted manner. - AI-assisted validation assistance
Whether automated traceability testing, AI-based test data generation, or NLP-supported requirements analysis: we show you how AI can accelerate your validation processes without compromising auditability. More about AI-supported software testing
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FAQs Software validation
Software validation is proof that software functions reliably and safely under specified conditions. It is a central component of the regulatory requirements in accordance with ISO 13485 and ISO 62304.
Because medical software performs potentially vital functions. Regulations such as the MDR, ISO 13485 and ISO 62304 prescribe validation to ensure patient safety and product quality.
The most important forms are
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Development validation (specifications met?)
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Installation validation (correct setup?)
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Operational validation (does it work in everyday use?)
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Performance validation (reliable under load?)
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Traceability validation (everything documented?)
- Verification: Have we built the product correctly? (e.g. unit tests, reviews)
- Validation: Have we built the right product? (e.g. UAT, real scenarios)
- Development
- Quality assurance / regulatory affairs
- External consultants, if applicable
- Departments / end users (for UAT)
AI is changing software validation in two ways. First, an increasing number of medical devices contain AI components (e.g., image diagnosis and therapy support) that must be validated according to the Medical Device Regulation (MDR) and the International Electrotechnical Commission (IEC) 62304 standard. These components have special requirements for explainability, fairness, and documentation of training data. Second, AI can streamline the validation process, offering automated traceability checks and synthetic test data generation. In both cases, we support you in using AI in a standards-compliant and audit-proof manner. Learn more about quality assurance for AI systems.
