We will help you compiling a 100% ISO-14971-compliant risk management file and developing safe products.
We will help you compiling a 100% ISO-14971-compliant risk management file and developing safe products.
We support you in creating the most important technical documentation files in the audit so that you not only obtain fast approval and marketing of your medical device, but also reliably identify and avoid risks for your patients and your company. This gives you security - in every respect.
Our risk management experts will work with you to
This gives you everything you need to meet ISO 14971 and thus the regulatory requirements in Europe and the USA (FDA) and thus pass your audit and approval with 100% certainty.
"With the practical help of Professor Johner and his team, we were able to establish a 'viable' QM system for our company and successfully certify it under ISO 13485 in just a few months. We really appreciate the pleasant cooperation and the fact that we were able to complete the project in the planned time and on budget."
Dominik Blei, Head of Development, Society for Patient Support
"Over the past two days, we have had an initial ISO 13485 audit with the TÜV. The audit found no non-conformities and only gave a few comments for improvements.
The risk management and usability files, which the auditors described as exemplary, received particularly high praise. We will therefore receive our certificate in the near future.
I would like to take this opportunity to thank you all on behalf of the entire team. We found working with you to be a very productive, valuable experience.”
Raimund Oberhammer, World-Direct eBusiness solutions GmbH
We get an overview of any existing documents and your product and, within two days, tell you exactly what you need to do in order to document your risk management file in compliance with the requirements of ISO 14971 and the FDA in a short time. We will then support you, for example
Find out how we can complete a project together.
Give us a call, send us an email or fill out the contact form so we can
With our support you will
Get in touch with us right away so that we can discuss the master plan that will help you obtain a compliant risk management file quickly and at low cost! You can contact us