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.
Get esay to understand introductory guidance about the approval process and legal requirements for medical devices.Download the Starter Kit
Do you have a specific question? Ask us and we'll answer with no obligation from you.Ask us a question
As auditors, engineers, members of standard committees, trainers of notified bodies we are experts in
Produce documents compliant to help get your medicl device aporovedWe can help produce compliant documents
Build a FDA and ISO 13485-compliant QM System.We can help you build and maintain a certified QM System
Watch training videos and use our templates to create compliant documentation.More about our templates and 70+ training videos
Become an expert in medical device compliance (FDA, IEC 62304, 62366 and ISO 14971 etc.).More about the certification seminar
Take advantage of our free products, develop your law-compliant medical products faster and smoothly go through the authorization:
We provide all the knowledge and information you need to create your own technical documentation according to the required standard:
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:
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!
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
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!