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[Podcast] Implementing Changes to SaMD under new EU MDR

September 6, 2019

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The Essentials: Regulatory requirements for medical device software

Summary of Key Points The key to address medical device software regulation starts with three questions: What does your software do? How do you plan to build it, and to test it? Requirements are the cornerstone for building and maintaining software throughout its lifecycle. The objective of regulatory agencies is to give a fair assessment whether your medical software is safe and it does what it‘s intended to do. From connective care devices to EMR systems, software is often an integral part of medical device technology, and even a medical device itself sometimes. The key to fully address medical device software regulation starts with three questions: What is your software intended to achiev

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