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We help you overcome regulatory challenges and bring safe medical devices to market faster.

News from the Johner Institute

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Download the Free AI Act Starter Kit

An overview of the new regulation and its demanding, imminent tasks for manu­facturers of AI-based medical and IVD medical devices.

Participants at a Seminar

Practical Workshop "AI Power for Medical Device Develop­ment"

Learn in just one day how to use large language models (LLMs) specifically in developing medical devices – from the initial idea to post-market surveillance. 

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Article "Medical Device as Trade Good"

Trade goods in the medical device sector can become a regulatory trap for distri­butors. This article provides you with a complete overview.

Our Services for your Success

Regulatorische Expertise und praktische Lösungen aus einer Hand

Regulatory expertise and practical solutions from a single source

What sets us apart? We offer more than just advice – we are your reliable partner from the initial analysis to successful implementation. Our inter­disciplinary team of lawyers, compliance experts, and process consultants works hand in hand to provide you with comprehensive solutions. We rely on proven methods combined with innovative approaches. From risk analysis and strategy development to implementation and ongoing moni­toring – we provide everything from a single source. The result: legally compliant processes, reduced compliance risks, and more time for what really matters – the growth of your business.

Regulation? We'll take care of it!

As your Legal Manufacturer, we assume liability and MDR compliance – you focus on innovation. Proven processes, immediately available resources, no regulatory delays.

4 markets, 1 partner – global representation

EU, UK, Switzerland, USA: We are your local authorised representative and open the doors to over 500 million patients. Compliance guaranteed, effort minimised.

From AI chaos to AI strategy

Already using ChatGPT & Co.? We transform your shadow IT into compliant processes and unlock the full potential of generative AI for development and regulatory affairs.

AI Act? No problem!

We guide you safely through AI Act compliance. From risk classification and technical documentation to conformity assessment – everything from a single source.

Hackers find vulnera­bilities – better we find them first

We are specialized in medical device pentesting according to IEC 81001-5-1. We think like attackers, document like auditors, and secure your approval.

Planning a clinical study? Looking for a synopsis!

The foundation of every successful evaluation: With our expertise and clever AI tools, you create watertight study synopses in record time – MDR-compliant and field-tested.

Your digital regulatory coach for a small budget

No 100,000€ for consultants? With the Auditgarant you learn everything step by step for MDR-compliant approval – including all templates to get started immediately.

Fully automated compliance monitoring

10,000 standards at a glance, Post-Market Surveillance on autopilot: Our Radar Software makes it possible. Use it yourself or outsource completely – you decide.

Your Quick Start into the World of Regulations

Runner at the Starting Line

Starter Kit

Get an overview of all the necessary regulations and standards so that you can quickly and safely get your medical and IVD medical device approved in the EU market.

 

We are always there for our customers

Feedback of our Customers

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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.
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
I'm so glad the Johner Institute exists! Outstanding expertise, excellent organization, very friendly team. For me, the Johner Institute is a guide/­compass in the endless ocean of the medical device world. Thanks to the publicly available specialist publications and the podcast, I always find a competent answer to the questions that arise from time to time in my daily work.
Dr. Shahbazian-Karaca Anaid Dürr, Dental SE
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
Thank you very much for two intensive and informative days of the “Internal Auditor” seminar, for the challenge, and the humor. The content and methods taught could be applied and tried out right away in the seminar. Very construc­tive feedback during the seminar, which encouraged all participants. The Johner Institute offered exactly what I was looking for. Grade A with a star.
Monika Schwarzhuber, medesign I.C. 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
Our one-day in-house seminar “IVDR for Medical Laboratories” was extremely successful. The technical content was presented clearly and comprehensively and conveyed in a surprisingly entertaining way. The efficiency and precision of the arrange­ments made with the seminar leader in advance deserve special mention. In addition, the content could be tailored to our company’s specific goals. All in all, a highly recommended event!
Thomas Schäfer, DKMS Life Science Lab gGmbH
Yesterday and today, we had the initial audit according to ISO 13485 with TÜV. They did not find any non-conformities and had only a few comments for improvement. The risk manage­ment and usability files were praised in particular and des­cribed as exemplary by the auditors. We will therefore receive our certificate in the near future. On behalf of the entire team, I would like to take this opportunity to thank you all very much. We found the colla­bo­ration with you to be very productive and appreciative.
Raimund Oberhammer, World-Direct eBusiness solutions 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
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
I particularly appreciate two things about working with JI. Excellent project planning combined with outstanding expert knowledge. The pilot concept allowed me to familia­rize myself with the topic under guidance and clarify any ques­tions I had through an indivi­dual correction loop. I can only recommend working with JI.
Reviderm AG Team
With the practical help of Prof. Johner and his team, we were able to establish a “workable” QM system for our company in just a few months and success­fully certify it according to ISO 13485. We greatly appreciate the pleasant cooperation and the fact that we were able to complete the project within the planned time frame and budget.
Dominik Blei, Gesellschaft für Patientenhilfe DGP mbH
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
The seminar was excellent. The lecturer taught the material in a very pleasant and educational manner. There were many practical exercises. It was actually quite enjoyable!
Marta Albis Camps, imusyn GmbH & Co. KG
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