Focus Areas – MedTech, Regulation, Quality, AI
🔗 Thematic focus at the intersection of MedTech, regulatory affairs, quality management, and AI in healthcare.
Language / Sprache / Sprog
🎯 How this page fits into my connector profile
This page outlines the main thematic areas that shape my development and way of thinking. These focus areas define where I position myself as a connector: between medical technology, regulatory requirements, quality and risk management, and practical healthcare workflows, with a regional emphasis on Germany, Denmark, and Sweden within a European context.
The goal is to show structure rather than breadth – a clear overview of the topics that guide my learning and work.
⚖️ MedTech regulation
My focus in MedTech regulation is on the link between frameworks and practical application:
- understanding how regulatory frameworks apply to specific medical technology products and processes
- identifying which requirements are relevant in a given context
- translating these requirements into structures, responsibilities, and documentation needs
The emphasis is on clarity and traceability: regulatory content should be understandable to those who work with it in practice, not only to specialists reading original texts.
🧪 Quality and risk management (ISO 13485, ISO 14971)
In quality and risk management, I think in terms of:
- processes – how work is actually carried out day to day
- roles and responsibilities – who is involved, accountable, and informed
- documentation and evidence – what needs to be recorded to support quality, compliance, and learning
Standards such as ISO 13485 and ISO 14971 serve as structural guides. For my connector role, the central questions are:
- how these standards are reflected in processes and responsibilities
- how risk‑based thinking becomes visible in decisions
- how systems can remain maintainable and understandable over time
🤖 AI in healthcare
For AI in healthcare, my focus is on structures and classification rather than on model development:
- considering how AI‑related approaches can be classified and assessed
- thinking in terms of risk, accountability, and responsibilities
- looking at how AI can be integrated into existing processes rather than added as a separate, poorly defined layer
The aim is to contribute to a structured view of AI in healthcare, where innovation is balanced with safety, quality, and clarity.
🌍 Regional and cross‑border perspective (DE–DK–SE)
These focus areas are always viewed in a regional context, especially along the Germany–Denmark–Sweden (DE–DK–SE) axis:
- understanding how expectations and practices differ between these systems
- observing how European frameworks are interpreted nationally
- identifying where alignment is needed for cross‑border work
This regional lens supports my connector role by highlighting interfaces and translation needs between different organisational and regulatory cultures.
💡 Key focus area insights
My thematic focus is defined by interfaces: between MedTech and regulation, quality and practice, innovation and structure. The goal is to use these focus areas to translate complex requirements into clear, sustainable workflows across regions.
🎯 How these focus areas shape my work
These focus areas guide how I:
- structure questions and information in projects
- prioritise learning and development
- connect regulatory, quality, and operational viewpoints in MedTech and healthcare