You want to implement regulatory requirements without any stress?
We make complex topics easy to understand!
What is biocompatibility and how do you prove it? Here we explain the topic from the beginning.
Preparation for the compilation of a clinical evaluation.
Fundamentals, tools and usable data
How to bring your medical devices legally into the U.S. market?
IVDs are an important but relatively unknown part of medical technology. But why?
We introduce you into the performance evaluation according to the IVDR!
All you need to know about the Medical Device Single Audit Program!
What is PMCF and how can this facilitate the MDR transition?
What is post-market surveillance and how does it work? - Basics of PMS.
Post-market surveillance, medical devices and the responsibility of the manufacturer.
Introduction to the topic "QM" and why it is so important.
Basics of risk management for medical devices and IVDs.
In a nutshell: Risk management for medical devices
What does usability mean for medical devices and IVDs?
What is vigilance in medical technology? In this article we explain the basics.