Johner Institut für IT im Gesundheitswesen

Johner Institute: A Leader in Medical Device Regulatory Services

The Johner Institute is 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? Ask us and we'll answer with no obligation from you.

Ask us a question
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Take 5 minutes to learn where your compliance weaknesses might be before your next audit.

Take the self-assessment

Our expertise and services

As auditors, engineers, members of standard committees, trainers of notified bodies we are experts in

  • Regulatory affairs (FDA, CE-marking),
  • Standards (e.g. ISO 14971, IEC 62366, IEC 62304, IEC 6060-1) and
  • Quality Management Systems (FDA 21 CFR part 820, ISO 13485:2016, ISO 9001:2015).
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Documentation for Market Approval

Produce documents compliant to help get your medicl device aporoved

We can help produce compliant documents
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Employee Compliance Training

Train your employees in quality management and the medical device approval process

We can train your and your employees

Our training topics include

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

More about our templates and 70+ 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
Support for any Budget

Take advantage of our free products, develop your law-compliant medical products faster and smoothly go through the authorization:

  • In our articles, you can find more than 100 knowledge based and informative articles that will answer your top questions.
  • In context of micro-consulting we will answer your question daily — and for free.
  • Our starter-kit gives you a glimpse of the regulations and the typical process of authorization, as well as audit.
  • The videos in our auditgarant are available for you without having to register

We provide all the knowledge and information you need to create your own technical documentation according to the required standard:

  • In the video trainings auditgarant, we show you step by step how to create a concise technical documentation fast and compliant with IEC 62304, ISO 14971 and IEC 62366. Even more in the premium-version, the templates for your documents are also included.
  • Combine the benefit of auditgarant with the allocated hours of our micro-consulting, for example to answer your top questions or to evaluate your documents.
  • With our seminars, you could improve your competency and increase both your and your company's value.

By developing your own competency, you will no longer be dependent on consultants, even on us :-).

If you are in a hurry with your project or have some resources bottleneck, we will guide you individually through your project:

  1. We will compose the basic structure of your documents and provide the exact instruction on how to complete it.
  2. We iteratively evaluate and improve your technical documents together with you, so that you can go through the authorization, as well as the audit smoothly and get your products straightly to the market.
  3. If necessary, we could take in charge of your project management and absolutely keep you accountable with your milestones :).

Contact us to discuss further how we could plan your project together and estimate the cost of your project. We are looking forward to hearing from you!

 Contact us

We do (almost) all the work for you, such as creating your complete technical documentation or your QM-handbook including all the descriptions of the process.

We think it is important to also transmit this knowledge to you — and because it is more difficult to achieve in this case —, we recommend this to you only

  • for exceptional cases (e.g problem in audit, time pressure),
  • for cases with bottleneck of capacity
  • if your already developed products have to be subsequently docummented. Yes, this will be a good option ;-).

Contact us now so that we can discuss how we could help you achieve your goals and accurately estimate the cost of your project. We are looking forward to hearing from you!

Contact us