Software Lifecycle Management Flashcards

How does IEC 62304 define 'legacy software'?

Answer: Software developed without a documented lifecycle process that must be evaluated and assigned a safety class

IEC 62304 defines legacy software as software developed prior to adoption of the standard or without a documented development lifecycle that must be evaluated, classified, and brought into conformance.

Which document in the medical software lifecycle describes the high-level structure of the system and how major components interact?

Answer: Software Architecture Document

The Software Architecture Document describes the high-level structure of the system, identifying major software items and their interfaces, providing the blueprint for detailed design and implementation.

When must software regression testing be performed in medical device software development?

Answer: After any software modification to ensure previously functioning capabilities are not broken

Regression testing must be performed after any software modification to verify that changes have not inadvertently introduced defects or disrupted previously validated functionality.

What triggers the requirement for re-validation of medical device software?

Answer: Any significant change that could affect the safety or effectiveness of the software

Re-validation is required for any significant change that could affect software safety or effectiveness, including changes to functionality, operating environment, or hardware platform.

What is the primary purpose of a formal software release process in medical device development?

Answer: To ensure a controlled, documented transition of software from development to production

The software release process ensures software transitions from development to production in a controlled and documented manner, verifying all lifecycle activities are complete before clinical deployment.

Why is maintaining version control throughout the medical software lifecycle significant?

Answer: It ensures reproducibility and enables accurate problem investigation and regulatory submissions

Version control enables specific software versions to be reproduced for problem investigation, audit reviews, or regulatory submissions, maintaining traceability throughout the entire lifecycle.

What is the role of a software maintenance plan in the medical device software lifecycle?

Answer: A plan defining processes for managing and implementing changes after software release

A software maintenance plan defines the processes and procedures for managing, evaluating, and implementing changes to software after its initial release, including problem resolution and planned modifications.