Johner Institut für IT im Gesundheitswesen

Johner Institute: A Leader in Medical Device Regulatory Services

Take your device to market as quickly and easily as possible.

With help from Johner Institute, you'll effortlessly navigate the
complex medical device approval processes (Europe/CE, USA/FDA).

Get started with free help today

Working through the medical device regulations and approval process can be overwhelming and challenging.

Use these resources to get an introduction to the process and legal requiremennts for your medical devices.

Download your Starter Kit, SSRS Checklist or get answers from an expert.

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Starter Kit

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

Learn more about 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 the SSRS checklist

Discover our services

Making sure your documentation, quality management, and testing is aligned for
medical device approval experience doesn't have to be as daunting as it may seem.

With our help, you not only have access to our expertise in document compliance,
quality management and usability testing. You will also be working out
our team of regulatory specialists, auditors, engineers and more.

Our services are specifically desigend to help you
pass medical device approvals and start selling your device.

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Compliant Documentation

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

Get help with producing compliant documents
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Quality Management

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

See how we can help with your 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.

Learn how we can help with usability testing

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

Download PDF with overview on our services

Learn more about our training topics

With our training you'll be equipped to solve problems now and in the future
as we give you the right concepts and models that are easy to implement.

Here are just a few reasons you'll appreciate our training:

  • You have online access, anytime and anywhere, with step-by-step guidance for every step of the way.
  • High-quality, professional production with concise training that's even fun to watch or attend.
  • Check yourself with tests to make sure that you've understood everything correctly.
  • Comprehensive with all documents, as well as templates for submission documents, ready to be used.
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Documentation

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

More about our templates and 60+ training videos
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Certification

Become an expert in medical device compliance (FDA, IEC 62304, 62366 and ISO 14971 etc.).

Learn more about the certification seminar
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Usability

Learn how to evaluate the safety and effectiveness of your product.

More about our usability trainings and services