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US Food and Drug Administration (FDA) and international regulatory standards continue to evolve and become more stringent as medical devices become more complex in design, functionality, and technological integration. This makes the process of medical device validation and verification even more important—not only to comply with regulations, but also to aid in the design of the highest-quality components and the production process. The desired result is better repeatability, fewer mistakes, less rework and redesign, faster time to market, improved competitiveness, and lower overall production costs.

For those new to medical device manufacturing (or those in need of a refresher), validation is the process of making sure that you have objective evidence proving that user needs and intended uses are met. It is usually performed through a variety of tests, inspections, and analyses. The goal of validation is to ensure that user needs are safely and effectively addressed in a medical device that consistently provides the intended medical benefit in actual-use conditions.

Fundamentally, the medical device validation process must include three key elements:

  • It must include initial production units built in the actual production environment using drawings and specifications that would typically be used by production personnel
  • It must involve clinical evaluation with actual end-users and the device tested either under simulated use or actual use
  • The device should be used under the specific environmental conditions of actual use (NOTE: clinical evaluation does NOT mean actual use on a patient – that typically involves considerably more process criteria and oversight)

During the medical device validation process, the device is thoroughly tested against every product and engineering requirement. Typical validation activities occurring throughout the medical device development process can vary depending on the risk-level of the device – Class I, II, or III. Tracking the data thoroughly and filing properly-completed documentation is critical because the FDA expects to see demonstrable evidence that all reasonable tests were performed in order to approve a medical device for use.

Reduce device approval risk with expert help

Our validation and verification experts here at MEDIcept can help you develop and implement thorough, effective, and appropriate medical device testing and process validation protocols and reports for better outcomes and lower risk.

Our state-of-the-art testing facility can provide the comprehensive testing services you need, including test feasibility, design and implementation, protocol development, and complete results interpretation and reporting. We can prepare and implement protocols for packaging and aging qualifications, sterilization validations, and biocompatibility testing final reports suitable for regulatory submissions.

Why take unnecessary risks when it comes to validating and verifying your medical device with the FDA and international regulatory agencies? Let MEDIcept be your trusted partner to guide you through the medical device validation process and help you get your device to market faster and more cost-effectively with less risk.

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