Why the Johner Institute?

We speak Medical Technology AND AI - for over a decade

Discover why leading medical technology companies trust us

13

Years of AI Experience

250+

+ successful projects

5000+

+ trained experts

Our AI DNA

A story of innovation and forward thinking

2012

The Beginning: Data Models for Regulatory Affairs

While others were still using Excel, we were already developing formal data models for regulatory processes - the foundation for today's AI applications.

2019

The AI Guideline is Born

Our AI guideline becomes the official standard of all Notified Bodies. We define how AI in medical devices is audited.

Milestone
2023

First LLM Prototypes

Start of development of specialized prompts and workflows for medical technology. Systematic testing of various LLM models.

2024

Enterprise AI Platform Launch

Our AI platform goes live. First customers achieve 70%+ time savings on regulatory documents.

2025

Market Leader for RegTech AI

1500+ medical technology companies follow our AI content. We are shaping the future of the industry.

Today

4 Reasons for the Johner Institute

What makes us unique

1

Domain Expertise

"We speak Medical Technology AND AI"

Others understand AI. Others understand medical technology. We master both at the highest level.

  • Trainer of Notified Bodies and authorities
  • Authors of regulatory standards
  • Practitioners with hundreds of successful projects
2

Field-Tested

"No Theory - Proven Solutions"

Our solutions don't come from the drawing board, but from real projects with real challenges.

  • 100+ optimized prompts in use
  • Proven workflows for all departments
  • Continuous improvement through user feedback
3

Regulatory Security

"We write the standards"

With us, you're not just compliant - you're ahead of the requirements.

  • MDR, IVDR & AI Act expertise firsthand
  • Direct line to Notified Bodies and authorities
  • Compliance by Design in all solutions
4

Holistic Approach

"Technology + People + Processes"

AI success requires more than software. We bring everything.

  • Technology: State-of-the-art infrastructure
  • People: Comprehensive training programs
  • Processes: Seamless integration into your workflows

Our Philosophy

"AI is not an end in itself, but an enabler"

We don't implement technology for technology's sake. Every solution must deliver measurable improvements: faster, safer, more efficient.

"Ontologies instead of hope"

Like Demis Hassabis (CEO DeepMind, Nobel Prize winner), we believe: Reliable AI needs structured data and clear models. We've been building these ontologies for medical technology since 2012.

"Humans remain at the center"

AI doesn't replace experts - it makes them more productive. Our solutions amplify human competence rather than replace it.

The Team Behind the Success

Interdisciplinary experts with a common mission

Prof. Dr. Christian Johner
Prof. Dr. Christian Johner

Founder & Visionary

AI Pioneer, Regulatory Expert

Dr. Catharina Bertram
Dr. Catharina Bertram

Head of IVD

AI Conformity

Dr. Sophie Bartsch
Dr. Sophie Bartsch

Senior Regulatory Affairs Expert

AI Application

Dr. Anja Kuhnert
Dr. Anja Kuhnert

Clinical Affairs Expert

Clinical AI Implementation

Prof. Dr. Christian Johner
Dr. Daniel Mölle

Chief Digital Officer

AI Application & Literacy

Over 50 additional experts work daily to make your AI transformation a success.

Our Vision for 2030

The Target Architecture for the Medical Technology Ecosystem

Connected Systems

All regulatory processes seamlessly integrated and AI-optimized

Real-time Compliance

Automatic adaptation to new regulatory requirements

Intelligent Assistants

AI agents available for every process step

We're not just building the future - we're already living it.

We Practice What We Preach

Our Own AI Transformation

The Johner Institute doesn't just use AI as a product - we've revolutionized our own processes:

  • 80% faster seminar preparation through AI-supported content creation
  • 95% automation in updating training materials
  • 60% more customer inquiries handled with the same team size
  • 100% AI literacy among all employees
Case Study: Our AI Journey
Challenge:

Exponentially growing regulatory requirements (now 10,000+ documents) with constant resources

Solution:

Step-by-step automation and AI integration of monitoring and analysis

Result:

3x more output with higher quality

Learn more about the Regulatory Radar →

Partnerships & Recognition

Official Trainer

Notified Bodies & Authorities

Standard Setter

AI Guideline for Medical Devices

International Network

DACH, Europe & USA

Ready for Your AI Transformation?

Become part of the success story. Let's start your AI journey together.

Or call directly:

+49 7531 94500 20

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