Meet Us at RAPS Convergence

Barbara M. Fisher leads the Johner Institute North America as President & CEO. After obtaining a Bachelor’s degree and an MBA from Duquesne University, she gained diverse experience in progressive marketing positions – especially within global business organizations – where she focused particularly on German-American business relations. 

Florian Krafft is Head of Consulting Services at the Johner Institute, but does more than just lead and grow our consultancy division. He also acts as a Project Manager for regulatory affairs projects, operating at the vital intersection between our internal departments and our clients.

Together, we enable MedTech companies to:

• plan and conduct HF studies that meet FDA expectations,
• structure and update regulatory documentation (including MDR, IVDR and FDA submissions),
• integrate HF, risk management and design decisions into a consistent story

Software solutions specifically for medical device and IVD manufacturers

• Regulatory Intelligence
• Regulatory Radar
• Regulatory Radar for Pharma
• Post-Market Radar
• AI Expertise

Focus on your core business – we will take care of your regulatory and administrative tasks efficiently, compliantly and cost-effectively.

• Authorized Representative Services & Regulatory Roles
• Legal Manufacturer

• Regulatory strategy for medical devices and SaMD
• MDR/IVDR, FDA and other jurisdictions
• Gap analysis of existing submissions and files
• Digital tools and templates to streamline RA work

• HF planning & strategy
• Formative and summative studies
• HF documentation that supports FDA and other authorities
• Integration with risk management and design decisions

Support services for all product types, management systems, and markets

• Market Access & Regulatory Affairs
• Management Systems
• Technical Documentation
• Change Management
• Digitalisation & AI
• Assisted Self-Service

First-hand, tried-and-tested, cutting-edge knowledge for all players in the medical device industry: 

• Seminars, Courses, Workshops
• InhouseExcellence
• E-Learning
• Podcast
• Auditgarant
• Johner Academy