We ensure that within a very short time, you get your medical product into the market with minimal cost.

We ensure that within a very short time, you get your medical product into the market with minimal cost

Fast Help With our Free Offers

Starter-Kit

The free starter-kit ensures that you have received an overview of the regularies and regular path to the audit.

Institute-Journal

Weekly inside tips to regularies and development of medical products. Follow the link to subscribe our free institutes journal.

Micro-Consulting

Our Experts answer your concrete question within 48 hours unbureaucraticly, competently and free

OUR EXPERTISE

Regulatory Affairs

Introduction to the regulatory frameworks and descriptions to the medical device approval processes.

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Medical Device Software & ISO 13485

Learn the steps on how to establish, audit and improve quality management systems.

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Software & IEC 62304

You will find hints on how to effectively and efficiently fulfill the requirements by IEC 62304 and the FDA.

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Risk-Management & ISO 14971

The most important requirement for medical device manufacturers is to understand how to determine the risk benefit ratio, how to analyze and mitigate risks and how to comply with ISO 14971.

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Usability Engineering & IEC 62366

Learn not only engineering usability and requirements, but also the methods to specify user interfaces and to verify and validate the usability with formative and summative evaluations.

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Product Development

Obtain insight onto the system architecture, definition of intended use, clinical evaluation, verification and validation and much more. Developing medical devices is much more than complying with regulations.

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About Us

We, the Johner Institute team, are united by our mission: to help medical device manufacturers overcome regulatory challenges and bring safe products to market quickly.

Our approximately 80 experts, including biologists, biochemists, physicists, computer scientists, engineers, physicians, medical engineers and psychologists, help you to make this dream come true.

Learn more about the team and about what drives us and is important to us.

"We are at the leading edge of supporting companies in developing and approving safe medical devices in a predictable, fast and precise manner."

Our Services

E-Learning / Auditgarant

Hundreds of companies are qualifying their employees on this E-Learning platform and create QM-systems with templates and admissiondocuments.

Starter-Kit

The free starter-kit ensures that you have received an overview of the regularies and regular path to the audit.

Institute Journal

Weekly insider tips on regulations and the development of medical devices. Follow the link to subscribe our free institutes journal.

Micro-Consulting

In range of our Micro-Consulting, we answer your questions daily - for free

Seminars

Build your own competence: develop medical products conform with IEC 62304, IEC 62366 and ISO 14971

Articles

In our Blog, you will find 100+ articles with answers to your most important questions.

Regulatory Affairs

This area includes 200+ tasks, to take care of at the development of medical products

Usability Testing

We help you create a IEC 62366-1 and FDA-compliant usability file in order to achieve approval quickly and cost-effectively.

QM-Systems

The ISO 13485 is a harmonized standard, which lays down the requirements for quality management systems (QMS) for medical devices.