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Learn about the essential testing methods and standards that ensure the safety and effectiveness of medical devices.
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The Design History File (DHF) is intended to be a clear, orderly record of how a product moved from concept to commercialization.
By: Dorian Simpson
How MAHD principles can help companies accelerate the transition to the FDA’s new Quality Management System Regulation (QMSR).
In this final column, we discuss two methods to help overcome the challenges that arise in development projects.
By: Russell M. Singleton, Aaron Joseph
In today’s competitive world, it does not make financial sense to redevelop technologies or subsystems that are readily available.
The final concept: Aligning quality system procedures to support and embrace these best practices.
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