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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.
Domains
Clause 7 — Software Risk Management Process
Clause 8 — Software Configuration Management Process
Clause 5 — Software Development Process
Clause 9 — Software Problem Resolution Process
Clause 4 — General Requirements
Compare IEC 62304:2015 Medical Device Software Lifecycle Processes
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IEC 62304:2015 Medical Device Software Lifecycle Processes by Industry
IEC 62304:2015 Medical Device Software Lifecycle Processes for Healthcare→IEC 62304:2015 Medical Device Software Lifecycle Processes for Financial Services→IEC 62304:2015 Medical Device Software Lifecycle Processes for Technology→IEC 62304:2015 Medical Device Software Lifecycle Processes for Government→IEC 62304:2015 Medical Device Software Lifecycle Processes for Manufacturing→IEC 62304:2015 Medical Device Software Lifecycle Processes for Energy→IEC 62304:2015 Medical Device Software Lifecycle Processes for Retail→IEC 62304:2015 Medical Device Software Lifecycle Processes for Education→
IEC 62304:2015 Medical Device Software Lifecycle Processes by Role
IEC 62304:2015 Medical Device Software Lifecycle Processes for CISOs→IEC 62304:2015 Medical Device Software Lifecycle Processes for Compliance Officers→IEC 62304:2015 Medical Device Software Lifecycle Processes for Risk Managers→IEC 62304:2015 Medical Device Software Lifecycle Processes for IT Directors→IEC 62304:2015 Medical Device Software Lifecycle Processes for DPOs→IEC 62304:2015 Medical Device Software Lifecycle Processes for Auditors→
Frequently Asked Questions
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.
How many controls does IEC 62304:2015 Medical Device Software Lifecycle Processes have?
IEC 62304:2015 Medical Device Software Lifecycle Processes contains 30 controls organized across 6 domains.
Where does IEC 62304:2015 Medical Device Software Lifecycle Processes apply?
IEC 62304:2015 Medical Device Software Lifecycle Processes is applicable in International. Organizations operating in or serving customers in this jurisdiction should evaluate its requirements.
What frameworks does IEC 62304:2015 Medical Device Software Lifecycle Processes map to?
IEC 62304:2015 Medical Device Software Lifecycle Processes has control-to-control mappings with 424 other compliance frameworks in our database. Use our compliance platform to explore these mappings interactively.
How do I get started with IEC 62304:2015 Medical Device Software Lifecycle Processes compliance?
Start by understanding the framework's key controls and domains. Our compliance platform provides AI-powered gap analysis and mapping tools to help you assess your current posture and build a remediation plan.
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