Software validation for medical devices
Regulatory safety begins with validated software. Whether CE marking according to MDR or approval by the FDA - no medical device is marketable without sound software validation. The requirements are high: processes must be documented in a traceable manner, test strategies must be implemented on a risk-based basis and all requirements must be fully verified and validated.
We help you to implement the complex regulatory requirements in a practical and efficient manner - in compliance with standards, audit-proof and future-proof.
Your benefits through MDR & FDA-compliant validation
Your benefits through MDR & FDA-compliant validation
The validation of medical software is not a bureaucratic end in itself - it creates the basis for safe, efficient and approvable products.
Your benefits at a glance:
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Regulatory safety
Compliance with the requirements of MDR (EU) and FDA 21 CFR Part 820 (USA) -
Market access worldwide
Eligibility for approval of your software products in Europe and the USA -
Verifiable quality & security
Seamless documentation and risk protection through structured tests -
Scalable processes
Validation solutions that fit your development model - whether agile or classic -
Shorter time-to-market
Thanks to clear validation strategies, structured documentation and fewer reworks
Herausforderungen Automotive SPICE und wie sepp.med unterstützt
Herausforderungen Automotive SPICE und wie sepp.med unterstützt
When MDR and FDA become a challenge - we deliver the right solution
The regulatory requirements for medical software are increasing - and with them the complexity for companies. There is often a lack of clarity about which standards apply, which evidence must be provided and how FDA and MDR requirements can be reconciled.
Typical problems:
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Lack of clarity about regulatory requirements (EU/US)
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Time pressure and lack of resources in the validation process
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Uncertainty in the creation of test plans, traceability & proofs
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Lack of integration into agile or classic development processes
Our solution:
We offer customized support for your software validation - from strategy to implementation:
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Validation strategy according to MDR, ISO 13485 & FDA requirements
Compliant with 21 CFR Part 820, Annex I of the MDR and ISO 62304 -
Document templates & checklists
For validation plans, risk assessments, traceability matrices, test reports and much more. -
Workshops & training
So that your team understands what is important in regulatory validation -
Test planning & test execution
Support with UAT, performance tests, traceability & more -
Audit preparation & review of your documents
So that you pass the notified body or FDA audit with confidence
AI and medical software: New requirements, proven expertise
Artificial intelligence is transforming medical technology in two ways: as a component of medical devices and as a tool in the validation process.
AI-based medical devices present new challenges for validation. Their behavior is non-deterministic, and their decision-making logic is often difficult to understand. Meanwhile, the EU AI Act classifies AI in medical devices as high risk. This means that MDR requirements and AI regulations conflict with each other directly. We support you in bringing these two areas together through bias testing, robustness testing, and audit-proof explainability documentation. Learn more about quality assurance for AI systems.
AI can also make the validation process more efficient by providing automated traceability analyses, generating intelligent test cases from requirements documents, and prioritizing targeted tests. AI-assisted software testing reduces effort without compromising regulatory evidence depth.
Healthcare and medical technology on the sepp.med blog
FAQs
The EU's MDR (Medical Device Regulation) requires software to be validated as a medical device - including documentation, risk management and evidence.
The FDA requires validation in accordance with 21 CFR Part 820, particularly in the context of design control.
Yes, but many requirements are similar (e.g. validation, verification, risk management). However, the scope of the documentation and the format differ.
- ISO 13485 (QM systems)
- ISO 62304 (Software life cycle)
- ISO 14971 (risk management)
- FDA 21 CFR Part 820
- IEC 82304-1 (for Health Software)
From planning and testing to the validation report - we support you in a structured, efficient and audit-ready manner.
