Product Verification & Validation Procedures

Medical device testing is a rigorous and complex process that demands careful planning and attention to detail. Our facility is equipped with a wide range of systems and tools enabling us to implement comprehensive product verification and validation procedures, including test feasibility, design and implementation, protocol development, and complete results interpretation and reporting.

Product Verification & Validation Procedures

We Prepare & Implement Protocols in Our Product Validation Process

Boulder iQ 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.

  • Design Verification & Validation

  • Usability Testing

  • Package/Ship Testing

  • Process/Equipment Qualification

  • Software/Integration Validation

  • IQ/OQ/PQ Process Validations

  • Product Biocompability Studies

  • Product & Accelerated Age Testing

  • Sterilization Validation