Johner Institute

Overview

This consulting firm, established in 2005 and based in Konstanz, Germany, specializes in regulatory compliance, quality management, and technical support for medical device manufacturers, particularly within healthcare IT and medical technology. The organization has experienced steady growth, serving clients with a wide range of services designed for the demanding requirements of international medical device markets.

Service offerings include technical documentation, quality management systems, usability testing, regulatory affairs training, and advanced software solutions such as eQMS and AI-driven regulatory data analysis. With comprehensive expertise, the company supports clients across the entire project lifecycle, driving initiatives in digital transformation and collaborating widely to expand their impact in the medical device sector.

Basic Information

Contact Details

• Phone: +49 753 19450020
• Website: johner-institut.de
• LinkedIn: linkedin.com/company/johner-institut

Key Focus Areas & Initiatives

• Regulatory compliance consulting for medical devices
• Quality management systems (QMS) compliant with ISO 13485 & FDA QSR
• Technical documentation and usability testing
• AI-powered data analysis for regulatory affairs
• Training, seminars, and e-learning for compliance
• Digital transformation programs for medical device companies
• Risk management and clinical evaluations

Technologies Used

• AI
• AWS SDK for JavaScript
• Amazon SES
• Apache
• Atlassian Confluence
• Bootstrap Framework
• CloudFlare Hosting
• Cloudflare DNS
• DoubleClick
• DoubleClick Conversion
• GitLab
• Gmail
• Google Apps
• Google Dynamic Remarketing
• Google Tag Manager
• Grafana
• Hotjar
• Hubspot
• Jira
• Linkedin Marketing Solutions
• Micro
• Microsoft Office 365
• Mobile Friendly
• Outlook
• React
• React Redux
• Remote
• Salesforce CRM Analytics
• StatCounter
• Trustpilot
• VueJS
• WebOffice
• WordPress.org
• reCAPTCHA

Buyer Teams to Target

Regulatory & Quality Affairs

• Head of Regulatory Affairs
• Regulatory Affairs Specialist
• Quality Assurance Manager
• QMS Lead
• Compliance Officer
• Risk Management Specialist

Engineering & Product Development

• Chief Technology Officer
• Medical Device Engineer
• Software Engineer
• Product Manager
• Usability Engineer
• Documentation Specialist

Operations & Compliance

• Director of Operations
• Clinical Affairs Manager
• Compliance Manager
• Audit Manager
• Process Improvement Lead
• Training Coordinator

Education & Digital Transformation

• Learning & Development Manager
• Training Program Director
• eLearning Coordinator
• Digital Solutions Lead
• AI Project Manager
• Transformation Consultant

What They Buy

• Cloud-based compliance management platforms
• Regulatory software & documentation solutions
• Clinical evaluation and usability testing tools
• Training platforms for medical device standards
• AI and data analytics technologies
• Secure hosting and IT infrastructure services
• Risk management and audit tools

Signals to Watch

• 📆 New job postings for regulatory, quality, or product roles
• 🚀 Launch or update of a compliance software tool
• 🤝 Announced partnerships with medical device manufacturers
• 🧑‍🎓 Expansion of training or e-learning programs
• 💰 Major funding round or acquisition activity
• 🔒 Mention of new cybersecurity or IT compliance needs