Product Testing

The Johner Institute supported us along our successful FDA 510(k) application with threat modeling and technical pen­tests. They showed great exper­tise and provided very useful answers to our questions and best practices. The cooperation and communi­cation were smooth throughout the process.

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.

Working with Ms. Gruber was truly wonderful at every stage! Emails were always answered quickly. Comments and sugges­tions were implemented promptly, and we always felt well advised.

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.

The Johner Institute is the per­fect partner for IT security. With their expert support, latest testing methods, and efficient solution approa­ches, we were able to improve the IT security of our medical software by performing penetration tests. The team has a high level of expertise, covering a wide range of software solutions and spe­cial requirements for artificial intelligence. We are completely satisfied and can recommend this service of the Johner Institute.

We had already been in contact with the Johner Institute several times regarding biocompatibility tests on our devices (pre-filled glass syringes) and were very satisfied with the advice and support we got, as well as how the tests were performed. The reports we received on the studies we commissioned were very well written, easy to under­stand, clearly structured, and presented the test results in an excellent manner. We would definitely recommend the Johner Institute to others.

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.

I want to express my warmest appreciation for the exceptional work of Giancarlo Florit as a security engineer. I had a chance to work with him twice during the security testing activities for our customer. Giancarlo demonstrated excep­tional knowledge in the medical device security testing following international standards and best security practices. We were faced with the situation to test the SaMD in accordance with secu­rity applicable standards and additionally comply with local Malaysian regulations and requirements. Giancarlo was willing to assist with the tests as well as the documentation required. Giancarlo was faced with testing the medical software taking into account GDPR/HIPAA and spe­ci­fic Malaysian PDP act as well as integrating the security risk-based approach into his prac­tice. Giancarlo was always in touch with the development team requests and was able to react really quickly to the changes. He was very proactive, well organized, and willing to assist even if it required more than it was expected at the beginning. He showed excep­tional communication skills that let us build strong and friendly relationships between Andersen, the Johner Institute, and other stake­holders. I recommend working with the Johner Institute as this is a really professional company with an appropriate well-educated staff. I surely hope to work with Giancarlo as well as with other team members from the Johner Institute on any future projects.

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.