About us
The Johner Institute is a trusted partner for the development and approval of medical devices, as well as for support and training on relevant topics related to regulations of medical technology. We provide our clients with a variety of quality solutions based on their exact needs.
Our primary clients are:
- manufacturers of medical devices and medical information systems
- hospitals, independent clinics and multi-site clinic chains
- notified bodies and authorities
- consulting companies and development service providers
We offer medical device manufacturers, their service providers and customers a comprehensive range of digital products and consulting services to help them work efficiently and avoid getting lost in the regulatory jungle. In doing so, we support manufacturers, for example, with defining their strategic pathways, writing regulatory documents, setting up lean and ISO 13485 compliant quality systems, product testing in our own labs, and post-market surveillance programs.
We are also committed to empowering individuals to meet the regulatory requirements for medical devices without unnecessary "overhead", and providing them with professional development tools to enable their personal growth, so that they become an even more valuable resource as employees and for their customers. Through our free offers, such as technical articles, medical device briefings, and micro consulting, as well as numerous training, study and event offers, we deliver vital knowledge that is essential to manufacturers, authorities, notified bodies and government.