COMPLIANCE ADVISORY
IEC 62304:2015 Medical Device Software Lifecycle Processes Readiness Advisory
A strategy call with someone who has spent 25 years building compliance systems used by 100,000+ professionals in 160+ countries – not a generalist who read the standard last week.
Why work with Ivanka on 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. Software safety classification (Class A, B, C) determines the rigor of required activities.
Most consultants approach IEC 62304:2015 Medical Device Software Lifecycle Processes as a checkbox exercise. Ivanka approaches it as a strategic lever. With 25 years of building The Art of Service – a compliance platform now covering 692 frameworks and 819,000+ cross-framework mappings – she doesn't just understand the standard. She understands how it connects to everything else your organisation is already doing.
This matters because IEC 62304:2015 Medical Device Software Lifecycle Processes doesn't exist in isolation. Ivanka will map your current compliance posture against the 30 controls across 6 domains, identify gaps, and show you where existing controls from other frameworks you may already follow can be leveraged – saving months of redundant work.
Relevant credentials
- Deep experience implementing ISO management systems across 160+ countries
- Experience guiding healthcare organisations through complex regulatory compliance landscapes
- MIT Entrepreneurial Masters graduate – rigorous analytical approach to enterprise challenges
- EXIN Expert Panel member – helping shape global certification standards
THE STRATEGY CALL
What you get in 30 minutes
Ivanka reviews your IEC 62304:2015 Medical Device Software Lifecycle Processes readiness scores and identifies the critical gaps that carry the highest risk. No generic advice – specific to your domains and controls.
A clear, prioritised plan for addressing gaps across 6 domains. She maps what you can leverage from existing compliance work and what requires new investment.
IEC 62304:2015 Medical Device Software Lifecycle Processes maps to 424 other frameworks. Ivanka shows you where a single control implementation can satisfy multiple regulatory requirements at once.
Domains covered in IEC 62304:2015 Medical Device Software Lifecycle Processes
Plus 1 additional domains. See the full assessment →
This is for you if
- You need to achieve IEC 62304:2015 Medical Device Software Lifecycle Processes compliance but don’t know where to start or how to prioritise
- You’ve been told you’re “compliant” but suspect gaps exist that haven’t been properly assessed
- You manage compliance for healthcare, technology organisations and need expert guidance, not generic templates
- You want to leverage existing compliance efforts across multiple frameworks rather than starting from scratch
- You need a strategic plan your leadership team and board will actually understand and support
Start with a free assessment. Then let's talk strategy.
Take the free IEC 62304:2015 Medical Device Software Lifecycle Processes readiness diagnostic. In 5 minutes you'll have a clear picture of where your gaps are. Then book the strategy call and Ivanka will show you exactly how to close them.
Free · No login required · Results in 5 minutes
Or go directly to the $149 Report + Strategy Call