Computer simulation serves as an essential tool for medical device designers and manufacturers. The growing use of computer simulation and modeling in the medical device industry helps reduce time and costs for exploring ideas, refining designs, and conducting prototyping and testing. Another critical benefit of computer simulation in the medical device industry is the level of accuracy achieved when evaluating device functionality.
While the level of precision has risen dramatically, so has the number of submissions for medical device approvals that include a simulation-data component. The Center for Device and Radiological Health (CDRH), a branch of the FDA that regulates companies that distribute, manufacture, or repackage medical devices, is responsible for qualifying computational models by verifying their credentials and intended purpose.
As the ultimate safety and effectiveness regulatory body between medical device manufacturers and patients, the FDA recognizes the value of such advancing technologies and the need to stay abreast of them. To keep up, the FDA has begun to actively encourage the use of simulation in device evaluation.
LTI offers materials testing, including metal and polymer testing and inspection services, for the medical device industry. A full range of materials testing is offered to provide information on the following:
- Material composition & identification
- Material properties & characteristics
- Defects & discontinuities
- Vulnerability to corrosion
Read an article in ASM’s Advanced Materials & Processes titled “FDA Recognizes Simulation Essential to Evaluate Medical Devices” to learn more about medical device innovations and the FDA’s recommendations on the continued use of computer simulation in medical device industry practices.
Contact our sales team to get a quote for your testing requirements.
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