Auditgarant

As a medium-sized company, the Auditgarant helps us to ensure that our documents comply with MDR and to identify any gaps. We benefit greatly from the expert sessions and the self-learning program, as we are not (yet) experts in medical devices ourselves. The templates provided by Auditgarant serve as a roadmap for us in the “MDR jungle.”

Both the reference to the document templates in the Auditgarant and the ongoing updates in the newsletter and on the Johner Institute blog were very helpful during the audit. Not only did we pass the audit with flying colors, we also received high praise from the auditor.

The Auditgarant helped us to set up our QMS within six months. The temp­lates ensured that we took into account not only the requirements of ISO 13485 but also those of the IVDR. That provides safety. We regu­larly use the video tutorials to expand our knowledge and reflect on certain topics. The Auditgarant has proven its worth for us!

With the help of the Auditgarant, we were able to successfully complete our MDR approval compliance process. We are grateful for the high-quality templates and e-learning courses, as well as the nume­rous answers to our questions. The e-learning courses are very easy to under­stand and focus on the essentials. The templates are all well structured and contain lots of helpful infor­mation to ensure everything is easy to follow.

As a young company without much background in the field of regulatory requirements for medical devices, we were faced with the major challenge of creating the framework for an approvable product. The Auditgarant supported us with helpful courses, information, and templates to acquire the necessary knowledge and competencies to overcome this hurdle. Initially, these newly acquired capabilities resulted in us successfully bringing a class I medical device to market. Thanks to the Auditgarant, we were able to solve our initial “problems,” questions, and uncertainties, and we are now moving forward with confi­dence.

We are very happy that we did so well in our MDR audit. The auditor said that this is very rare. Investing in the Auditgarant was well worth it! Many thanks to the entire Johner team for creating the Auditgarant with all the docu­ments!!! We couldn't have done it without you!

The Johner Institute's Auditgarant was a great help with our first submi­ssion. Thanks to the e-learning, the comprehensive templates, and the always helpful team, we were able to comply with the MDR requirements and prepare structured submission docu­­ments for our class IIb device.

We are a newly founded com­pany striving for ISO 13485 certification. First of all, the Johner Institute's Auditgarant convinced us. In an industry subject to strict regulatory requirements, it was crucial for us to find a partner who could guide us through the some­times complex processes. From the very first contact, the Johner Institute team was extremely professional and supportive. We would like to express our special thanks to Mr. Wettlaufer and Mr. Heimerl. In our opinion, the resources and templates provided in the Auditgarant are comprehensive and up to date with the latest legal require­ments. Particularly noteworthy is the practical support that helps us to set up our internal processes for the first time. Thanks to the continuous updating of the Auditgarant, we aim to use it in the long term to optimize our processes and ensure their compliance. We particularly like the fact that the learning units not only present the content of, for example, a standard that must be met, but also describe valuable sugges­tions for effi­cient creation and imple­men­tation. We can warmly recommend the Auditgarant to any company starting out in the medical technology industry. We are convinced that the Auditgarant is an investment that will pay off in every respect.