IEC 62304:2015 Medical Device Software Lifecycle Processes
What is IEC 62304:2015 Medical Device Software Lifecycle Processes?
IEC 62304 defines the lifecycle requirements for the development and maintenance of medical device software. It specifies processes, activities, and tasks for each stage of the software lifecycle including planning, requirements analysis, architectural design, detailed design, unit implementation, integration testing, system testing, release, and maintenance. It comprises 99 controls organised across 6 domains, and applies in International.
How IEC 62304:2015 Medical Device Software Lifecycle Processes maps to other frameworks
All 99 controls, each one mapped to the equivalent requirement in other standards, with the evidence that carries across and the mappings that were judged and rejected shown alongside. No account needed to look.
See the control mappings →The 6 domains IEC 62304:2015 Medical Device Software Lifecycle Processes groups its controls into
Where IEC 62304:2015 Medical Device Software Lifecycle Processes overlaps with the standards you already hold
Where to get trained on IEC 62304:2015 Medical Device Software Lifecycle Processes
4 courses in the catalogue cover IEC 62304:2015 Medical Device Software Lifecycle Processes directly. Each is self-paced, includes the downloadable toolkit and the implementation playbook, and carries a certificate of completion.
Training more than one person? Ten seats of any course is $1,490 on a single licence, against $199 a seat bought one at a time.
What IEC 62304:2015 Medical Device Software Lifecycle Processes means in your sector
What IEC 62304:2015 Medical Device Software Lifecycle Processes means for your job
Questions people ask about IEC 62304:2015 Medical Device Software Lifecycle Processes
What is IEC 62304:2015 Medical Device Software Lifecycle Processes?
How many controls does IEC 62304:2015 Medical Device Software Lifecycle Processes have?
Where does IEC 62304:2015 Medical Device Software Lifecycle Processes apply?
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How do I get started with IEC 62304:2015 Medical Device Software Lifecycle Processes compliance?
Query IEC 62304:2015 Medical Device Software Lifecycle Processes programmatically
IEC 62304:2015 Medical Device Software Lifecycle Processes, its 99 controls and every mapping into other standards are available over a REST endpoint and an MCP server, so an agent can read them directly. The free tier is 10 calls a day and needs no signup.
IEC 62304:2015 Medical Device Software Lifecycle Processes API reference and MCP config →What IEC 62304:2015 Medical Device Software Lifecycle Processes requires, control by control
Each page carries the requirement text for one IEC 62304:2015 Medical Device Software Lifecycle Processes control and what an assessor expects to see as evidence.
- 4-1 Quality Management System
- 5-1 Software Development Planning
- 5-2 Software Requirements Analysis
- 5-3 Software Architectural Design
- 7-2 Risk Control Measures
- 7-3 Verification of Risk Control Measures
- 7-4 Risk Management of Software Changes
- 8-2 Change Control
- 9-4 Use Change Control Process
- 9-6 Analyze Problems for Trends
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