Johner Institute: A Leader in Medical Device Regulatory Services
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 checklistDiscover 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.
Compliant Documentation
Produce documents to help get your medical device FDA- and CE-approved.
Get help with producing compliant documents
Quality Management
Build a FDA (21 CFR part 820) and ISO 13485-compliant Quality Management (QM) System.
See how we can help with your certified QM System
Usability Testing
Ensure usability of your devices and compliance of your usability file with FDA and IEC 62366 regulations.
Learn how we can help with usability testingOur 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
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.
Documentation
Watch training videos and use our templates to create compliant documentation.
More about our templates and 60+ training videos
Certification
Become an expert in medical device compliance (FDA, IEC 62304, 62366 and ISO 14971 etc.).
Learn more about the certification seminar
Usability
Learn how to evaluate the safety and effectiveness of your product.
More about our usability trainings and services