Language / Sprache / Sprog
English (current) · Deutsch – Start / Kurzprofil · Dansk – Start / Kort profil
Start / Short Profile
🎯 At a glance
- Who I am: Connector in development at the intersection of MedTech, regulation, quality, AI in healthcare, and real‑world practice.
- Where I focus: Early‑stage and evolving MedTech environments, especially across Germany, Denmark, and Sweden (DE–DK–SE).
- What this site shows: How I think and work in a supportive, structure‑oriented role – not a finished consulting profile.
🔗 Developing a connector role between medical technology, regulation, quality management, AI in healthcare, and real‑world healthcare practice.
👤 How this page fits into my connector profile
This page provides a short overview of my developing connector role. I work at the intersection of medical technology, regulatory affairs, quality management, AI in healthcare, and practical healthcare workflows, with a regional focus on Germany, Denmark, and Sweden (DE–DK–SE).
I am consciously in development in this role: my contribution today is to structure questions, align expectations, and translate complex requirements into clear, realistic steps, especially in early‑stage or evolving MedTech environments.
This site is intended to show how I think and work as a connector in development, not to present a finished consulting profile.
🧠Home / overview
I work at the intersection of medical technology, regulatory requirements, quality management, AI in healthcare, and real‑world healthcare processes.
My focus is on translating complexity into clear structures, aligning technical, regulatory, and operational expectations, and supporting cross‑border contexts between Germany, Denmark, and Sweden.
I help clarify open questions around regulation, quality, and processes, especially in early‑stage or evolving MedTech environments. My strength lies in structuring information, making requirements actionable, and connecting different perspectives into coherent workflows.
🗂️ Website structure
This website is organised into a small set of focused pages:
- Profile & Background – professional path and foundational perspective.
- Connector Role (in Development) – concept, scope, and development path of my connector role.
- What I Do – Current & Developing Capabilities – where I can contribute today and what I am building towards.
- Focus Areas – MedTech, Regulation, Quality, AI – thematic focus fields.
- Regions – Germany, Denmark, Sweden (European Context) – regional lens and structural differences.
- Working Style & Principles – Dennis Grundmeyer – how I think and work in practice.
- Services for small MedTech manufacturers – services and scope of structural support.
- Portfolio – Selected Work (EN) – selected examples of structures and process work.
- Contact & Networking – Dennis Grundmeyer – how to get in touch and what kind of exchange I am looking for.
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🔧 What I work on today
- Regulatory affairs in MedTech – understanding and structuring regulatory requirements for medical technology and relating them to products, processes, and responsibilities.
- Quality and risk management (ISO 13485 / ISO 14971) – thinking in terms of processes, roles, documentation, and risk‑based decisions.
- AI in healthcare – considering how AI‑related topics can be classified, assessed, and integrated into healthcare and MedTech contexts within regulatory and quality frameworks.
- Cross‑border structural alignment – paying attention to how structures and expectations differ between Germany, Denmark, and Sweden, and how they can be made compatible in practice.
🎯 Why this work matters
Early‑stage MedTech environments, healthcare processes, and regulatory demands often collide in complex and ambiguous ways. Structured, process‑oriented thinking helps to:
- reduce confusion around what is required and who is responsible
- prevent gaps between regulatory texts and day‑to‑day operations
- create realistic, stepwise approaches instead of ad‑hoc reactions
- support teams in making decisions that are both compliant and workable in practice
My contribution is to help make these connections visible and operational.
🤝 How I can currently support
In smaller companies and early‑stage environments, I can contribute in supporting roles, especially when:
- complex regulatory or quality‑related questions need to be structured and organised
- information has to be translated into clear steps, processes, and responsibilities
- different perspectives – technical, regulatory, operational, and organisational – need to be brought together in a coherent picture
My focus is on helping to create clarity, realistic next steps, and structures that can be used in day‑to‑day work.
📬 Contact & networking
Open for professional exchange on MedTech, Regulatory Affairs, Quality Management, AI in Healthcare, and cross‑border collaboration (DE–DK–SE).
- E‑mail: *dennis.grundmeyer.work@gmail.com*