On Tuesday September 20 from 10:00 to 10:45 hours CEEIARAGON organizes a technical conference in digital format to publicize the regulation of medical devices in Europe aimed at manufacturers, with practical application in MedTech and medical software.
Medical devices must comply with CE marking regulations for their entry into service in Europe. When it comes to products with a high level of innovation, such as medical software, medical applications or products incorporating novel technology, compliance with these regulations becomes more complicated. This conference will clarify some of the necessary concepts, prior to placing medical devices on the market, that innovative products must comply with, such as: licenses, administrative procedures and permits; CE marking of medical devices and quality systems.
The conference will be given by Isabel López Guerrero, a chemistry graduate with more than 15 years of experience in the medical sector. Isabel is also founder and CEO of EpisKey Medical Consulting, a company dedicated to helping emerging companies developing new technologies to regulate their innovative medical devices. She has worked for different companies and Notified Bodies, as a strategic consultant and regulatory mechanisms advisor in the international and EU regulatory landscape.
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