Call Us Today at 508-231-8842        EMERGENCY

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.

Sign up to receive our Newsletters!

The Latest News

medical device microchip board

Are You a Start-Up? We Can Help.

Last year the US medical device industry achieved over $150 billion in sales, making it one of the most lucrative industries in the country. However, launching a medical device start-up in this highly regulated industry can be fraught with challenges. Medical product start-ups need to minimize regulatory and compliance risk to attract early-stage investors and save money. To complicate matters even more, recent changes in FDA regulations make it more important than ever to limit potential...

Covering All Angles of Quality Assurance

Every responsible medical device manufacturer is aware that the FDA requires them to establish and follow quality systems to help ensure that their products consistently meet applicable requirements and specifications – a protocol known as current good manufacturing practices (CGMP). These requirements were written into the original regulation issued back in 1978, which was revised, starting in 1990, into a broader and more consistent quality system (QS) regulation that is in effect today. Of...

FDA Inspection? We Can Help You Relax.

Nothing can strike fear into the heart of a medical device manufacturer quite like an unexpected notice from the FDA. How you prepare for an FDA inspection? What is the process? What are they going to look for? Are they really that mean? After the inspection how do you respond to a 483 notice or worse what happens if you received a warning letter? How you perform during the inspection can make all the difference in the world between a quick resolution and a long expensive remediation program....