About the Guest Lecturer
Christian Rosenzweig is a Senior Consultant for Medical Devices with over 25 years of professional experience in healthcare and medical technology. As a biomedical engineer (Diplom-Ingenieur), he combines deep technical understanding with comprehensive regulatory and quality management expertise.
His career path led him from the development of complex active medical devices and over a decade of software development to leading roles in quality management for international corporations. Today, he advises companies as a consultant at the Johner Institute, guiding them safely through the regulatory jungle – practically, structured, and with an eye for the essentials.
Expertise & Experience
Key Areas of Expertise
- Medical Device Regulation (MDR, international regulations)
- Supplier Quality Management
- Technical Documentation
- Risk Management (ISO 14971)
- Software Lifecycle Processes (IEC 62304)
- IT Security & Cyber Resilience Act (IEC 81001‑5‑1)
- Threat Analysis & Information Security
Professional Background (Selection)
- Johner Institut GmbH – Medical Devices Consultant (since 2019)
- CYMEDSEC – Member of the Advisory Board
- B. Braun Group – Head of Quality / Quality Management Representative for Active Medical Devices, Quality Manager Active Medical Devices
- iSYMED GmbH – Software Engineer for Active Medical Devices (over 12 years)
- Fresenius Medical Care – Project Engineer
- Clinical experience as a certified nurse (emergency room)
Project Experience
- Support for several global companies in the transition from MDD to MDR
- Establishment and maintenance of regulatory processes according to ISO 13485, ISO 14971, IEC 62304, IEC 81001‑5‑1
- International quality and supplier structures
The Elective Course
Title
The Gateway to the MedTech Industry:
Regulatory Know-how for Suppliers
Brief Description
This elective course provides suppliers and aspiring MedTech professionals with a practical understanding of regulatory requirements in medical technology. Participants learn about the regulatory expectations manufacturers have for their suppliers and how these can be systematically met.
The focus is on understanding regulatory requirements not as a hurdle, but as a strategic competitive advantage. Using concrete examples from industry and consulting practice, Christian Rosenzweig shows how suppliers can become regulatory compliant early on and build sustainably successful customer relationships.
What you will learn
01
clearly classify the regulatory role of suppliers in the MedTech environment
02
understand and apply relevant requirements from MDR, ISO standards, and other standards
03
anticipate typical regulatory expectations from manufacturers
04
identify and evaluate risks along the supply chain
05
translate regulatory requirements into processes and documentation in a structured way
06
communicate confidently with quality, regulatory, and development departments
Practical added value: Participants gain clear guidance on which regulatory "basics" are required as a supplier to be perceived as a professional and reliable partner.
Format & Dates
Format & Duration
Format: Online
Duration: 2-4 hours
Language: German or English
Cost: TBD
Target Audience
- Suppliers for the MedTech industry
- Sales & Business Development profiles with MedTech relevance
- Product managers & Project managers
- Quality and Regulatory managers
- Software and IT service providers in the MedTech environment
Use this elective as a solid introduction to the regulatory requirements of the MedTech industry and gain a clear knowledge advantage as a supplier.
Contact & Registration: