Table of Contents

What is IEC-62304?

Functional Safety is an important consideration in the design and maintenance of medical device software. IEC 62304 is a functional safety standard that covers the safe design and maintenance of software. It provides processes, activities, and tasks to ensure safety. These apply to the development and maintenance of medical device software when: The software is itself a medical device; when it is used as an accessory to a medical device; when it adjusts or modifies the functionality of a medical device; or when it interacts with a patient.

How to establish IEC-62304 Compliance with a Requirements Management Tool?

Medical device industry is an industry that does not have any space for mistakes or errors. Therefore, using professional software like Visure Requirements for managing requirements is a smart move for medical device developers. 

What will you learn in this complete guide?

  • What exactly is IEC-62304?
  • Why must you use a Requirements Management Tool?
  • What features does Visure provide to help you comply with IEC-62304?

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