Johner Institut für IT im Gesundheitswesen

Johner Institute: A Leader in Medical Device Regulatory Services

Take your device to market as quickly and easily as possible.

With help from Johner Institute, you'll effortlessly navigate the
complex medical device approval processes (Europe/CE, USA/FDA).

Get started with free help today

Working through the medical device regulations and approval process can be overwhelming and challenging.

Use these resources to get an introduction to the process and legal requiremennts for your medical devices.

Download your Starter Kit, SSRS Checklist or get answers from an expert.

Starter Kit

Get esay to understand introductory guidance about the approval process and legal requirements for medical devices.

Learn more about the Starter Kit

Ask an Expert

Do you have a specific question? Our medical device and regulatory affairs experts answer with no obligation from you.

Ask us a question

SSRS Checklist

Check whether that your software system requirements specification (SSRS) meets FDA and IEC 62304 requirements.

Download the SSRS checklist

Discover our services

Making sure your documentation, quality management, and testing is aligned for
medical device approval experience doesn't have to be as daunting as it may seem.

With our help, you not only have access to our expertise in document compliance,
quality management and usability testing. You will also be working out
our team of regulatory specialists, auditors, engineers and more.

Our services are specifically desigend to help you
pass medical device approvals and start selling your device.

Our team and our expertise

The Johner Institute team reassembles awarded

Regulatory affairs specialists
Auditors (at European notified bodies)
Members of standard committees
Engineeres, (computer) scientists
Trainers of the European notified bodies
Physicians

Professor Johner's team consists of highly specialized experts for

Regulatory affairs, FDA approval, CE-marking
Standards: IEC 62304, ISO 14971, IEC 62366, and IEC 60601-1
Medical devices with embedded or stand-alone Software
Software engineering and software processes
Risk analysis, assessment and management
Requirements & usability engineering and usability testing
Quality management: FDA 21 CFR part 820, ISO 13485:2016

Download PDF with overview on our services

Learn more about our training topics

With our training you'll be equipped to solve problems now and in the future
as we give you the right concepts and models that are easy to implement.

Here are just a few reasons you'll appreciate our training:

You have online access, anytime and anywhere, with step-by-step guidance for every step of the way.
High-quality, professional production with concise training that's even fun to watch or attend.
Check yourself with tests to make sure that you've understood everything correctly.
Comprehensive with all documents, as well as templates for submission documents, ready to be used.