Medical Device Validation and Verification Testing
During the next phase of the medical device development process, you will be working to further evaluate, verify, and validate, and if successful, freeze your device design through pre-clinical and early feasibility testing.
At this stage, you may need to refine or further develop your regulatory strategy based on the results obtained during pre-clinical testing. You will be developing systems and processes to document your development process. You may need to further identify or refine specific user requirements and technical specifications, along with initiating a preliminary medical device risk analysis.
During the validation and verification stage, Aptiv Solutions can help you to:
- Develop and implement systems and procedures to effectively document the medical device design history process
- Implement risk management and design validation processes and procedures
- Identify the most appropriate and relevant testing standards and requirements for your technology