Technical Document­ation

Document Review with the Team

We help you to quickly and safely get your medical and IVD medical devices approved with complete technical documentation that complies with the law.

We create the conditions for successful approval of your medical and IVD medical devices in the target market and provide reliable support in preparing the required documents and files in the following areas:
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We are always there for our customers

Feedback of our Customers

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HeVaTech GmbH has been working with the Johner Institute for several years. Together, we have created the CER and all technical documen­tation for our medical devices. Mr. Bethäußer provided us with expert and timely support in classifying and creating the TD. We would like to express our sincere thanks for this. We would also like to thank Ms. Wettlaufer and Ms. Penn for their expert support in creating the CER. We can recommend the Johner Institute as a consulting partner to any medical device manufacturer!
Sigmar Hengge, HeVaTech GmbH
The Johner Institute was once again a competent and reliable partner in the timely submis­sion of our tech­nical documen­tation in accor­dance with MDR. We greatly appreciate the friendly and straight­forward advice and the trusting coope­ration with the Johner Institute. Especially in these turbu­lent times, it is very helpful to have a service provider with such diverse compe­tence at our side.
Moritz Freimut, Stihler Electronic GmbH
As a young start-up, we were faced with the challenging task of perfor­ming usability evalu­a­tions with US citizens directly in the US. The Johner Institute proved to be an extremely valuable partner, providing us with crucial support in success­fully achieving our objective. The collaboration was characte­rized by a high degree of profes­siona­lism and produc­tivity. We were able to rely on the team's compre­hensive expertise and reliable support at all times.
neotiv GmbH Team
Thank you very much for your assistance, which has been very helpful to us. We have always felt that we received sound and professional advice.
Ralph Reitmajer, MTS Medical UG
We always receive very quick and competent feedback from the Johner Institute. The offers are individually tailored to our problems and we can rely 100% on the work and statements we receive from the Johner Institute. We are glad to be able to request such support!
Alexa Tulaszewski, Telos GmbH
Many thanks for your support. It was a great professional expe­rience for us and we learnt a lot. We will certainly address our next studies and activities to Johner Institute.
Vittorio Iormetti, B Medical Systems S.a r.l.
Our request was handled very professionally and promptly from the outset. The consultant quickly familiarized herself with the subject matter and handled the entire clinical evaluation process in a very thorough manner. We will gladly call on the services of the Johner Institute again if necessary.
Andreas Heltschl, Heltschl GmbH Medizintechnik
For us as a start-up, the Johner Institute, with its Auditgarant and always appro­priately selected contact persons, is an essential source of support and guidance for all kinds of topics and inquiries, whether it's setting up the QMS or individual topics such as usability. In the area of usability, for example, we had an open flank. Starting with the basics and moving on to implemen­tation within product develop­ment, we built up internal know-how with the help of Dr. Philipp Schleer, planned our approach, and filled the neces­sary templates with life. Philipp was always available to answer our ques­tions. We really appreciate the fact that the contact persons for the various topics always remain the same at the Johner Institute, so that we can pick up where we left off at any time.
TEDIRO Healthcare Robotics GmbH Team
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