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Consulting
Market Access
Market Access US & International
Market Access Europe
MDR / IVDR Consulting
IVD Admission Strategy
AI Medical Devices
And more…
Quality System
Quality management systems (ISO 13485)
ISO 13485 audits
Quality management representative
Quality management system as a service
Technical Documentation
Software (IEC 62304, FDA)
Risk Management (ISO 14971)
Clinical Evaluation
Performance evaluation of IVDs
Electrical Safety & IEC 60601
Human Factors / Usability (IEC 62366 and FDA)
FDA relevant documents
Product test
Human Factors Research
Safety and EMC test laboratory
Biological safety
Computer System Validation
Seminars
Seminar Overview
Digital Transformation
Medical Device University
Regulatory Intelligence
Post-Market Radar
Regulatory Radar
About us
The Company
Our Mission
Our Values
Certificates
People
The Team
Our Customers
Locations
Jobs at Johner Institute
Current Vacancies
Why the Johner Institute?
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Article author Dr. Nils Becker
Dr. Nils Becker
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