Verification and Validation Testing Challenges of Medical Devices
The adoption of medical devices has evolved in the healthcare industry in recent years. Medical devices are used to diagnose and for therapeutic purposes. As they grow smaller and more complex, verification and validation (V&V) of devices become more important.
Design V&V of medical devices ensures that specific design requirements and user needs are met. For example, companies must ensure that devices are within the acceptance criteria defined by test methods and specifications and can be used consistently. In addition, companies need to validate that the device meets customer requirements. They should also prioritize the security and safety of devices, for it involves the risk of life.