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

Can we help you with that?

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

OUR EXPERTISE

Regulatory Affairs

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

LEARN MORE

Medical Device Software & ISO 13485

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

LEARN MORE

Software & IEC 62304

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

LEARN MORE

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.

LEARN MORE

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.

LEARN MORE

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.

LEARN MORE

Health Care

Countries such as Germany, Austria, Switzerland or the USA spend more than 10% of their gross national product on their health systems. However, the systems differ greatly in their efficiency and effectiveness.

LEARN MORE

Johner & Institute

Get the latest news about the institute and Christian Johner

LEARN MORE

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.

group

"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