Our free Starter-Kit provides you with an overview of the governing laws and regulations and guidance through a typical medical device approval process.
The Johner Institute's newsletter keeps you updated on changes affecting the Medical Device and IVD industry.
Our Experts provide answers and offer guidance to your questions within 48 hours for free and without obligation.
Level up your medical device skills! From quick, hands-on lessons to comprehensive certifications, you'll learn everything you need to know to stay current in the medical device industry.
Thanks to automation, you can quickly and efficiently fulfill your legal obligation to post-market surveillance and ISO 14971 compliant post-market risk management.
We navigate you safely through the jungle of laws and regulations and ensure that you get global market access for your medical device.
We support getting your QMS ISO 13485:2016 and 21 CFR 820 compliant or establishing a QMS from scratch with our eQMS solution.
We help you create an IEC 62366-1 and FDA-compliant usability file and conduct formative and summative evaluations to achieve approval quickly and cost-effectively.
Demonstrate product compliance with clinical trials, usability testing, and electrical and biological safety testing.