E-Learning

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Start your individual training now and master the approval process for your medical and IVD medical devices on your own

Fulfilling regulatory tasks in the medical device sector is extremely demanding. Many complex and constantly changing regulations must be understood and implemented. 

Our e-learning offerings provide a flexible option for education and further training as individually needed, overcoming regulatory hurdles independently, and even successfully obtaining approval for your medical or IVD medical device. 

The content of our e-learning offerings is regularly updated and expanded in line with legislation so that you always stay up to date. 

Our E-Learning Offerings for MedTech Manufacturers

Johner Academy

✓ 350+ video training sessions and task-based courses on regulatory require­ments

✓ 5 audit-proven best practices

✓ 7 exclusive webinar records

✓ 40 integrated self-tests and certificates that prove learning success 

Auditgarant

✓ Entire e-learning library of the Johner Academy

✓ 90+ ready-to-use templates and check­lists for technical documentation and other approval documents

✓ 80+ templates for your turnkey and streamlined quality management system according to ISO 13485:2021

✓ Weekly expert sessions on relevant regulatory topics

✓ Individual onboarding 

We are always there for our customers

Feedback of our Customers

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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.”
Silvia Henke, Alsitan GmbH
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.
Joachim Köninger, HeartGo GmbH
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!
Frank Münzinger, Aignostics GmbH
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.
Melanie Henze, Preventicus GmbH
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.
Matthias Hippe, Mediceo GmbH
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!
Anja Discher, DISCHER Technik GmbH
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.
Sabine Dörner, EyeSense GmbH
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.
Max Power Life Science GmbH Team
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FAQ: Answers to Frequently Asked Questions about our E-Learning Offerings

Who is the Johner Academy, and who is the Auditgarant suitable for?

The Johner Academy is an education platform suitable for beginners or career changers with little or no regulatory knowledge and more experienced individuals who want to expand their knowledge and competencies. 

The Auditgarant is particularly suitable for medical and IVD medical device manufacturers who want to save costs for external services and master device approval themselves. The newly acquired knowledge can be directly implemented with the help of various templates and checklists in the Auditgarant. 

How does the content of the Johner Academy differ from that of the Auditgarant?

The Johner Academy focuses on building theoretical knowledge in regulatory affairs and quality management. 

The much more comprehensive Auditgarant, with its numerous templates and checklists, enables manufacturers to implement legal requirements directly in practice and bring their devices to market independently. 

Users of the Auditgarant automatically have access to the learning content of the Johner Academy. 

Is the Johner Academy also suitable as a learning platform for the entire company?

The Johner Academy is ideal for general training and education in regulatory affairs and quality management. 

Instead of relying exclusively on basic courses and advanced seminars, your employees can build up their competencies flexibly and independently at their own pace, regardless of location and when needed.  

Use your employees' personal certificates as proof of competence in your QM system and ensure audit success. 

How do I become a member of the Johner Academy or the Auditgarant?

We want to provide you with as much transparency as possible to help you decide.   

That's why we start by providing you with further information and an initial insight into the Johner Academy and the Auditgarant during a joint consultation.   

You can then clarify any individual questions you may have about membership and request a customized offer. 

Are the e-learning certificates recognized by auditors and notified bodies?

You can find a detailed answer to this question in the FAQ section specifically for our digital solutions. 

Do members of the Johner Academy or the Auditgarant have a contact person for specific concerns and feedback?

Our e-learning team constantly contacts all members and keeps them informed about new learning content, functions, and other relevant topics. 

As a member of the Johner Academy or the Auditgarant, you can always contact our team with product-specific questions or feedback. 

You haven't found the right answer to your question, or have a specific request?
​​​​​​​
​​​​​​​Feel free to contact us. 

 

Contact us, we're happy to help!
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