Critical software in regulated sectors requires extremely high levels of quality: reliability, safety, traceability and regulatory compliance. Errors or non-compliance can result in sanctions, risks to users, operational failures and reputational damage. SQS works in sectors such as railway and medical devices where quality is a legal requirement, not merely a competitive advantage.
Why Do Regulated Environments Require Specialized QA?
- Direct safety risk. A defect in railway, medical or aeronautical software can have a real impact on human lives.
- Strict standards that must be met
SQS works with standards such as:
• EN 50126/50128/50129 in railway
• IEC 62304 and MDR/IVDR in medical devices
• ISO 14971 for risk management
• IEC 61508 for functional safety - The need for complete traceability. Every requirement must be linked to its design, code, test and result. Lack of traceability is one of the main causes of regulatory non-conformities.
How to Ensure Quality in Regulated Environments
- Validation and Verification from the design phase. SQS integrates V&V from requirements, V-model, design and structured testing.
- Functional risk management. Applying ISO 14971/IEC 61508 to identify, analyse and mitigate risks is crucial.
- Exhaustive and fully documented testing. Static, unit, integration, system and final acceptance tests, supported by complete audit trails.
- Independent audits and assessment. SQS offers internal and external audits to ensure compliance before CE marking or third-party validation.
If your company develops software in regulated sectors, you need a specialized partner. SQS has certified experience in railway, medical devices and industrial environments.
Request a compliance audit to detect gaps and accelerate your certification.
