About me Services Process Projects Kontakt
Portrait
Curriculum Vitae

Ulrich Schwanke

Career Timeline
1985–1993
1994–1998
1999–2005
2005–2015
2015–present
Education
Medical Studies
  • Heinrich-Heine-Universität, Düsseldorf
  • Interrupted by 18 months of civilian service at Düsseldorf University Hospital
  • Medical licence (Approbation)
Medical Training
Clinical Further Training
  • Neurosurgery, VITREA Clinic Hattingen
  • Radiologie, Josefs-Hospital Dortmund
IT & Consulting
DocCheck AG, Köln
  • Development of DocCheck password protection & web-based services
  • Relational database model for the backend
  • Development of DocCheck intranet, web front-end programming
  • Middleware and website programming (Cold Fusion, HTML)
  • CRM setup, online market research and online studies
Market Access Medical Dev.
kon.med GmbH
  • Market entry strategies and business model development for medical devices
  • Support for medical device approval procedures
  • Reimbursement strategies (DRG, EBM, GOÄ, integrated care contracts)
  • Specialist retail concepts (orthopaedic suppliers, home care, pharmacies)
  • Concepts for the private-pay market
Regulatory Affairs
Schwanke Healthcare Consulting
  • Training as Senior Consultant, MEDRAS GmbH
  • Independent consultant since 2022
  • Founder and owner of Schwanke Healthcare Consulting
  • Tätigkeiten siehe Services
Memberships
Member of the Management Board

HealthCareShapers is a network of healthcare experts that actively shapes the transformation of healthcare. It brings together stakeholders from medicine, technology, consulting and industry to develop and disseminate innovative solutions for patient-centred, digital and sustainable healthcare.
www.healthcareshapers.com
Association for Electrical, Electronic
& Information Technologies
VDE is one of the largest technical-scientific associations in Europe with over 100,000 members. It connects science, standardisation and application in electrical engineering, electronics and information technology. In the medical device context, VDE is particularly active in standards development, AI system approval and digital health standardisation.
www.vde.com
Regulatory Affairs Professionals Society – Germany

RAPS is the world's leading organisation for regulatory affairs professionals in healthcare. The German section connects experts from industry, authorities and academia, offers training and promotes exchange on regulatory requirements for medical devices, medicines and diagnostics.
raps-germany.de
Professional Development
01
Lead Auditor ISO 13485:2016
2017 · BSI Training Academy
  • Training Course
02
Software as a Medical Device
2019 · DIN Akademie
  • Regulatory and normative requirements
  • Software validation
03
AI in Medical Devices
2024 · VDE
  • Hands-on Training
04
Continuing Education
2015 to present · DNV MECERT, MEDRAS, VDE
  • Risk management per EN 14971
  • Various continuing education courses on MDR
  • MDCG Guidance Documents
  • Quality Management System Regulation (formerly 21 CFR 820)