Author: John Campbell | December 2, 2021
Medical device software development is an evolving field within the medical device industry—growing more complex each day to keep up with the need for enhanced patient care and therapies. As medical device manufacturers develop software to support their devices, they need to be aware of the nuances, processes, and regulations associated with software development.
To ensure the safe design, development and maintenance of medical software, manufacturers must adhere to the IEC 62304 standard, a framework that defines processes, activities, and tasks across every phase of the medical device software development lifecycle. Because the standard is harmonized with regulatory requirements from both the US and EU, the IEC 62304 is generally used as a key benchmark within the two markets.
Medical device software development lifecycleprocesses as defined by IEC 62304
Safety classification and the medical device software development lifecycle
Per the IEC 62304 standard, the manufacturer must assign a safety class to the software system based on its potential to create a hazard that could result in an injury to the user, the patient, or other people. The three safety classes for software include:
The software safety class assigned impacts the entire software development lifecycle — from requirements and coding to release and maintenance. While you will likely conduct verification, integration, and system testing on your software regardless of the safety classification, the degree to which you perform each activity will vary considerably.
Establishing the safety and effectiveness of your device’s software is essential to your ability to comply with IEC 62304. At Sterling PLM, we are experts in the medical device software development lifecycle. Using Polarion, an industry-leading application lifecycle management software solution, we’ll help you define, build, test and manage complex and embedded software systems to support smooth medical device product development across the entire lifecycle.
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