COMPLIANCE ADVISORY
EU Medical Devices Regulation (MDR 2017/745) 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 EU Medical Devices Regulation (MDR 2017/745)
Regulation (EU) 2017/745 on medical devices replaces Directives 90/385/EEC and 93/42/EEC. It establishes a comprehensive regulatory framework for medical devices in the EU covering the entire product lifecycle from design and manufacturing through post-market surveillance. Applies to all medical devices placed on the EU market. Fully applicable since May 2021.
Most consultants approach EU Medical Devices Regulation (MDR 2017/745) 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 EU Medical Devices Regulation (MDR 2017/745) doesn't exist in isolation. Ivanka will map your current compliance posture against the 20 controls across 4 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
- 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 EU Medical Devices Regulation (MDR 2017/745) 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 4 domains. She maps what you can leverage from existing compliance work and what requires new investment.
EU Medical Devices Regulation (MDR 2017/745) maps to 442 other frameworks. Ivanka shows you where a single control implementation can satisfy multiple regulatory requirements at once.
Domains covered in EU Medical Devices Regulation (MDR 2017/745)
This is for you if
- You need to achieve EU Medical Devices Regulation (MDR 2017/745) 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 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 EU Medical Devices Regulation (MDR 2017/745) 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