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, MDCI 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
Contact us today to learn more about medical device validation and verification.
Contact Us
Reach our Massachusetts office at 1-508-643-0434, Monday through Friday, 9:00 a.m. to 5:00 p.m. Eastern. Or fill out our contact form and a consultant will contact you directly.
Client Testimonial
I look forward to working with you to complete the entire process and to celebrate the ultimate success of achieving FDA 510(k) clearance. I cannot think of better partners or a better team to achieve this final result!
- U.S. manufacturer and developer of a dental device