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).
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.
Get esay to understand introductory guidance about the approval process and legal requirements for medical devices.Learn more about the Starter Kit
Do you have a specific question? Our medical device and regulatory affairs experts answer with no obligation from you.Ask us a question
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.
Produce documents to help get your medical device FDA- and CE-approved.Get help with producing compliant documents
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
The Johner Institute team reassembles awarded
Our team consists of highly specialized experts for
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:
Watch training videos and use our templates to create compliant documentation.More about our templates and 60+ training videos
Become an expert in medical device compliance (FDA, IEC 62304, 62366 and ISO 14971 etc.).Learn more about the certification seminar