Medical Device Software — Software Life Cycle Processes
The international standard defining life-cycle requirements for medical device software — development, maintenance, risk management, configuration management, and problem resolution. It classifies software into safety classes A, B, and C by the severity of harm a failure could cause and scales the required rigour accordingly.
Software that is part of a medical device or is itself a medical device (SaMD), across its development and maintenance life cycle.
- 01Assign and justify a software safety class (A, B, or C)
- 02Plan and document the software development life cycle
- 03Integrate software risk management with ISO 14971
- 04Operate configuration management and problem-resolution processes
The 2006 standard plus Amendment 1 (2015) clarified legacy software and safety classification; widely referenced by FDA and harmonized under the EU MDR.
IEC 62304:2006+A1:2015: frequently asked questions
Quick answers to common questions about IEC 62304:2006+A1:2015.
What is IEC 62304:2006+A1:2015?
IEC 62304:2006+A1:2015 — Medical Device Software — Software Life Cycle Processes — is a standard issued by the International Electrotechnical Commission. The international standard defining life-cycle requirements for medical device software — development, maintenance, risk management, configuration management, and problem resolution. It classifies software into safety classes A, B, and C by the severity of harm a failure could cause and scales the required rigour accordingly.
Who does IEC 62304:2006+A1:2015 apply to?
Software that is part of a medical device or is itself a medical device (SaMD), across its development and maintenance life cycle.
What are the key requirements of IEC 62304:2006+A1:2015?
IEC 62304:2006+A1:2015 requires, among other things: Assign and justify a software safety class (A, B, or C); Plan and document the software development life cycle; Integrate software risk management with ISO 14971; Operate configuration management and problem-resolution processes.
When was IEC 62304:2006+A1:2015 last updated?
The current version of IEC 62304:2006+A1:2015 dates from June 2015. The 2006 standard plus Amendment 1 (2015) clarified legacy software and safety classification; widely referenced by FDA and harmonized under the EU MDR.
Live openFDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.
Track the standards that move
When IEC 62304:2006+A1:2015 — or any GxP requirement — is revised, recalled against, or clarified by new guidance, the Weekly GxP Briefing surfaces it. Free, one email a week.