october, 2020

30octAll DayFree Online Regulatory & Clinical Affairs check-up | October 30,2020(All Day: friday)

medtech regulatory clinical affairs checkup medtech

Event Details

Medidee and POCdx Organizing Committee are delighted to offer a 1-hour free regulatory and clinical check-up with our experts on Friday, October 30.

The event will be online.It is dedicated to Medtech companies (MD and IVD) that may have questions related to the classification of their medical device / IVD or that are questioning the classification of their products as medical devices, the conformity assessment route or the requirements in terms of clinical evidence.

Example of topics that might be covered:
• Classification strategy (under MDD/IVDD and MDR/IVDR) of a complex systems, borderline products
• Clinical evaluation requirements of innovative IVD devices
• Conformity assessment route and the context of Covid-19 crisis
• Evaluating your regulatory positioning
• Evaluating the impact of new European regulations (MDR & IVDR) on your strategy
• Confirming or building a safe plan including quality and clinical aspects.

Any question? Please send an email to Silvia Anghel (silvia.anghel(at)medidee.com).

Time

All Day (Friday)

Location

Online Event

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