Verification and Validation

Intertech has been an innovator in medical device and software validation since the 80’s. Our software validation services are highly process driven throughout the product development lifecycle. Our validation engineers work with Intertech’s processes, with the client’s processes, or can supplement client processes with Intertech processes.

Our validation experience extends beyond the validation of medical devices and device software. We also have expertise in validating software for use in the device manufacturer’s quality or production systems. This type of validation is regulated under 21 CFR 820.70(i).

Our validation team works with clients in a hands-on, consultative, or training role on areas of expertise including:

• Verification and Validation SOP Development and Streamlining
• V&V Planning
• Requirements Management and Traceability
• Test Design, Test Case, Test Procedure Development
• System, Integration, and Unit Level Testing
• Regression Test Planning
• SBT, ad hoc, and use case driven testing
• Defect/Issue Tracking and Management
• User Testing
• Reviews, Walkthroughs, and Inspections