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.

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.

IEC 62304:2015 Medical Device Software Lifecycle Processes

Q: 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.

Q: 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.

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

Frequently Asked Questions

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