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Day 4  
Day 4 Thursday (following week) | 9.00 am to approx. 3.45 pm | FDA inspection and vigilance requirements  
Module 3 | 510(k) premarket notification: part II (in the morning, the following week)  
Module 3 | 510(k) premarket notification: part II (in the morning, the following week) Pre-submission communication with the FDA: enquiries, pre-submission procedures General documentation…  
Module 2 | 510(k) premarket notification: part I (in the morning)  
Module 2 | 510(k) premarket notification: part I (in the morning) Basic FDA requirements and an introduction to 510(k) documentation Editing the eSTAR template Key element: ‘Substantial…  
Module 1 | FDA requirements (full day)  
Module 1 | FDA requirements (full day) Background and fundamental regulatory requirements of the FDA, the agency’s activities, the definition of ‘medical device’, specific considerations for…  
Module 4 | FDA inspection & vigilance requirements (six hours)  
Module 4 | FDA inspection & vigilance requirements (six hours) FDA Inspection: The 5 most common findings during an FDA inspection Regulatory framework (FD&C Act, Code of Regulations),…  
Get to know your trainers  
Cathrin Lechner worked for over three years as a usability engineer at an IVD manufacturer after completing her Master’s degree in Mechanical Engineering, specialising in medical technology. There,…  
Regulatory Intelligence  
Our Regulatory Intelligence SaaS keeps you up to date through regulatory monitoring and ensures company-wide compliance.  
IVD Performance Studies  
We help you ensure the quality of your analytical and clinical performance studies for in vitro diagnostic medical devices and their results.  
IVDR Expert Session  
With the IVDR expert session, you gain clarity on the qualification of your in-vitro diagnostic medical devices and the best approval strategy in only one hour.  
Events of the Johner Institute  
The Johner Institute not only actively participates in many industry events but also organizes its own events.  
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