Johner Institut für IT im Gesundheitswesen

Johner Institute: A Leader in Medical Device Regulatory Services

The Johner Institute will help you navigate the medical device approval process (Europe/CE, USA/FDA)
getting your device to market as quickly, easily, and safely as possible.

Start by getting help for free

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Starter Kit

Get esay to understand introductory guidance about the approval process and legal requirements for medical devices.

Download the Starter Kit
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Ask an Expert

Do you have a specific question? Our medical device and regulatory affairs experts answer with no obligation from you.

Ask us a question
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SSRS Checklist

Check whether that your software system requirements specification (SSRS) meets FDA and IEC 62304 requirements.

Download SSRS checklist

Our services

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Compliant Documentation

Produce documents to help get your medical device FDA- and CE-approved.

We can help produce compliant documents
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Quality Management

Build a FDA (21 CFR part 820) and ISO 13485-compliant Quality Management (QM) System.

We can help you build and maintain a certified QM System
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Usability Testing

Ensure usability of your devices and compliance of your usability file with FDA and IEC 62366 regulations.

We can plan and test the usability of your medical device

Our team and our expertise

The Johner Institute team reassembles awarded

  • Regulatory affairs specialists
  • Auditors (at European notified bodies)
  • Members of standard committees
  • Engineeres, (computer) scientists
  • Trainers of the European notified bodies
  • Physicians

Professor Johner's team consists of highly specialized experts for

Our training topics include

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Watch training videos and use our templates to create compliant documentation.

More about our templates and 60+ training videos
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Become an expert in medical device compliance (FDA, IEC 62304, 62366 and ISO 14971 etc.).

More about the certification seminar
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Learn how to evaluate the safety and effectiveness of your product.

More about our usability trainings and services