Verification and Validation

Medical device testing is a rigorous and complex process that demands careful planning and attention to detail. Ourfacility is equipped with a wide range of systems and tools enabling us to provide comprehensive testing services, including test feasibility, design and implementation, protocol development, and complete results interpretation and reporting.

Boulder BioMed can help develop and execute qualification testing and process validation protocols and reports. We can prepare and implement protocols for packaging and aging qualifications, sterilization validations, and biocompatibility testing final reports suitable for regulatory submissions. We can also apply these same skills to testing conducted at your facility on your processing equipment.

Specific testing services include:

• Design verification and validation
• Usability testing
• Package/Ship testing
• Process/equipment qualification
• Software validation
• Integration validation
• IQ/OQ/PQ process validations
• Product biocompatibility studies
• Product & accelerated age testing
• Sterilization validation