Medical Imaging Software

Prototyping is crucial in medical device development for functional testing, identifying issues, and ensuring compliance with safety and regulatory standards.

Modern software is built on layers of open-source and third-party components—bringing both innovation and risk. In regulated industries, especially those handling sensitive data or critical systems, understanding exactly what’s inside your software is no longer optional. That’s why Software Bill of Materials (SBOM) has become a key requirement for security, compliance, and supply chain transparency.

Verification and Validation (V&V) are two pillars that ensure a medical device is safe, effective, and compliant before it ever reaches patients. The verification process and validation process occur throughout the product development cycle – from initial design through production and post-market changes – and they serve as formal “checkpoints” to confirm quality and performance. In short, V&V is not just a regulatory box to tick – it’s a fundamental part of risk management, quality assurance and the testing process that protects users and companies alike, and ensures regulatory compliance.