Our free Starter-Kit provides you with an overview of the governing laws and regulations and guidance through a typical medical device approval process.
The Johner Institute's newsletter keeps you updated on changes affecting the medical device and IVD industry
Our Experts provide answers and offer guidance to your questions within 48 hours for free and without obligation.
We navigate you safely through the jungle of laws and regulations and ensure that you get global market accesss for your medical device.
Hundreds of companies are qualifying their employees on the Johner Institute's E-Learning platform, gaining a better understanding of QM-Systems, and preparing required submission documents with our templates.
Helps medical device manufacturers keep track of constantly changing regulations and make the right findings from these changes. Regulatory Radar helps you achieve improved compliance and even saves you work and money.
We help you create a IEC 62366-1 and FDA-compliant usability file in order to achieve approval quickly and cost-effectively.
We, the Johner Institute team, are united by our mission: To help medical device manufacturers overcome regulatory challenges and quickly bring safe products to market.
Our team of approximately 150 subject matter experts worldwide, including biologists, biochemists, physicists, computer scientists, engineers, physicians, medical engineers, and psychologists, work closely with clients to exceed their goals by simplifying and expediting time to market.
Click here to learn more about the team, our values, and what drives us.