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IEC 62304 and the Medical Device Software Development Lifecycle

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

  • Software development process: Part 5 of the standard describes everything from software development planning, requirements analysis, and design to unit, integration and system verification and testing, and software release.
  • Software maintenance process: As defined in part 6 of the safety standard, the software maintenance process must include a software maintenance plan, problem and modification analysis, and modification implementation.
  • Software risk management process: Part 7 of the standard includes the analysis of the software contributing to hazardous situations, risk control measures and a verification of those control measures, risk management of software changes, and security and reliability through software quality.
  • Software Configuration Management Process: Part 8 of the standard defines software configuration identification, change control, and configuration status accounting.
  • Software problem resolution process: And finally, part 9 delves into problem reports, investigations, advising relevant parties, maintaining records, trend analysis, software problem resolution verification, and more.

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:

  • Class A: No injury or damage to health is possible.
  • Class B: Injury is possible, but not serious.
  • Class C: Death or serious injury is possible.

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.

For more information about Polarion and how it can help you manage your medical device product development lifecycle and compliance documentation, contact us here.


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