verification & validation

V-MODEL orientated development is one of the common standards in quality orientated development.

plock consuling could guide and support you through the complete development process, starting at definition of requirements and specifications through development and implementation up to test design- and execution of tests during verification and validation.

verification

"Is the product developed as specified?"

• - according to its design and system specifications?
• - according functional specifications?
• - according regulatory requirements (essential requirements, performance, safety)?

8.1.1 Verification planning and controlling
8.1.2 Verification Master Plans, Verification Plans from system-level to component-level
8.1.3 Verification Test Design and Execution
8.1.4 Design of pc evaluated measurement places
8.1.5 Test Reports

validation

"Is the product developed right according requirements? "

• - according to its intended use?
• - according to regulatory, essential requirements for safety and performance?
• - cost effective?
• - easy to use?

8.2.1 Validation planning and controlling
8.2.2 Clinical Evaluations
8.2.3 Clinical Studies
8.2.4 Usability Studies
8.2.5 Summary Reports