Question 1

What are medical device standards, and why are they important for healthcare software?

Accepted Answer

Medical device standards are regulatory guidelines ensuring healthcare software meets safety, quality, and performance criteria, protecting patient welfare, and ensuring compliance with global regulations.

Question 2

Which international standards apply to medical device software development?

Accepted Answer

Key standards include ISO 13485 for quality management, IEC 62304 for software lifecycle processes, and ISO 14971 for risk management.

Question 3

How does IEC 62304 impact healthcare software development?

Accepted Answer

IEC 62304 provides a framework for the software development lifecycle, including risk management and testing, ensuring reliable and safe medical device software.

Question 4

What is the role of ISO 14971 in medical software compliance?

Accepted Answer

ISO 14971 focuses on risk management, guiding developers in identifying, assessing, and mitigating potential hazards in healthcare software.

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