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.
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:
Regulatory safetyCompliance with the requirements of MDR (EU) and FDA 21 CFR Part 820 (USA)
Market access worldwideEligibility for approval of your software products in Europe and the USA
Verifiable quality & securitySeamless documentation and risk protection through structured tests
Scalable processesValidation solutions that fit your development model - whether agile or classic
Shorter time-to-marketThanks to clear validation strategies, structured documentation and fewer reworks
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.
Lack of clarity about regulatory requirements (EU/US)
Time pressure and lack of resources in the validation process
Uncertainty in the creation of test plans, traceability & proofs
Lack of integration into agile or classic development processes
We offer customized support for your software validation - from strategy to implementation:
Validation strategy according to MDR, ISO 13485 & FDA requirementsCompliant with 21 CFR Part 820, Annex I of the MDR and ISO 62304
Document templates & checklistsFor validation plans, risk assessments, traceability matrices, test reports and much more.
Workshops & trainingSo that your team understands what is important in regulatory validation
Test planning & test executionSupport with UAT, performance tests, traceability & more
Audit preparation & review of your documentsSo that you pass the notified body or FDA audit with confidence
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.
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.
From planning and testing to the validation report - we support you in a structured, efficient and audit-ready manner.
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