V&V and compliance with standards

V&V activities and compliance with international standards are the foundation of device excellence.

Our verification, validation, and standards compliance expertise transforms complex requirements into streamlined testing strategies that prove your device works as intended and meets global safety benchmarks and regulatory requirements.

Standards Strategy & Planning

We help you navigate the complex world of applicable standards:

• Mapping relevant standards to your device (IEC 60601-1, IEC 60601-1-2, IEC 62304)

• Creating tailored testing matrices based on your device's risk profile

• Developing efficient V&V plans that minimize redundant testing

• Determining appropriate test sample sizes and protocols

• Strategizing pre-clinical testing approaches that satisfy multiple requirements

  
  

Comprehensive Testing Support

We guide you through the full spectrum of required testing:

• Biocompatibility and chemical characterization (ISO 10993)

• Sterilization validation (ISO 11135, ISO 11137, ISO 17665-1)

• Reprocessing and cleaning validation

• Usability engineering (ISO 62366-1)

• Packaging integrity (ISO 11607)

• Software validation (IEC 62304)

• Safety and EMC testing (IEC 60601-1, IEC 60601-1-2)

• Animal origin materials compliance (ISO 22442)

• Device Specific standards and guidelines

• Mechanical bench testing

  
  

Evidence Integration & Submission Readiness

We transform test results into compelling regulatory evidence:

• Creating comprehensive V&V reports that satisfy regulators

• Addressing testing/non-testing rationales with viable solutions

• Building evidence packages for global submissions

• Ensuring test documentation traceability