Overview: Before the design process is completed and your product or device is ready for the marketplace, verification and validation are imperative.
Evidence must be recorded that the performance of V&V was successful. How these two process are performed and recorded may be cause for violations during an audit or investigation. Issues discovered during the post-market surveillance of a device often can be linked to drawbacks associated with the verification and validation process. This webinar will provide the attendee with a definition of Verification and Validation and identify the methods for performing these processes properly. The process of mapping a device specification from conception to validation is vital in confirming a device’s conformance to its indications for use. The tools and methods needed for a proper verification and validation of a design will be outlined during this presentation. Software which has become more and more prevalent in the design and test of devices also has an effect on the V&V process especially when third party software is included with the device. Identifying the responsibility for each element of the verification and validation process is key to successful completion of V&V. Consideration must also be given to Human Factors associated with your device and the connection to your Risk Management Process as well.
Areas Covered in the Session:
Verification & Validation: Their Similarities and Differences: