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We are state-of-the-art in the validation process

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,...

MDSAP: Cybersecurity and the single audit process program

For those who may not be entirely familiar with the Medical Device Single Audit Program (MDSAP), this initiative is intended to allow auditors from MDSAP-recognized Auditing Organizations (AOs) to conduct a single audit of a medical device manufacturer’s quality management system that will satisfy the requirements of the medical device regulatory authorities participating in the MDSAP program. The countries currently participating in the program include the United States, Canada, Japan,...

Medical Device Single Audit Program: What you need to know, Pt. I

Both the medical device industry and international regulators have witnessed the growing need for a standardized, worldwide approach to auditing and monitoring medical device manufacturing. A single, comprehensive process would reduce costs and speed time to market. With that goal in mind, the International Medical Device Regulators Forum (IMDRF) began work several years ago to create a program framework that would enable the conduct of a single regulatory audit of a medical device...