Practical guide based on SQS experience
In the most regulated sectors (railway, medical devices, energy, critical industry), software quality is not just a technical requirement: it is a safety, compliance and, in many cases, reputational requirement. A failure can result in sanctions, product withdrawals or risks to human safety.
This is why organisations look for partners capable of supporting them throughout the entire product lifecycle with solid procedures and rigorous audits.
What makes quality so complex in regulated environments?
• Long lifecycle processes, exhaustive documentation and auditable evidence.
• Strict traceability requirements (IEC 61508, EN 50128/50129, IEC 62304…).
• Combined software and hardware validation.
• The need to demonstrate compliance to certification bodies.
The pillars that make the difference
At SQS we work with an approach that reduces time, risks and costs:
• Clear, traceable requirements: from design to verification.
• Strategic automation: where it brings reliability and real return on investment.
• Independent validation: essential to avoid bias and comply with standards.
• Continuous risk management: integrating safety + cybersecurity.
• Audit-ready evidence: processes designed for compliance.
Benefits for organisations
• Shorter time-to-certify.
• Lower probability of non-conformities.
• Increased reliability and product lifespan.
• Enhanced confidence for auditors and end customers.
Quality cannot be improvised. In regulated environments, it is a path guided by methodology, experience and the ability to support technical teams. That is the value SQS provides.
