Dear Team,
We are pleased to invite you to our next exciting workshop series on Medical Devices by Voisin Consulting Life Sciences.
The workshops Medical Device from EU to USA and Introduction to Medical Software Development will cover the following topics;
1. Medical Device from EU to USA
EU/US Regulatory Strategies for Medical Devices & Digital Health Solutions: What are the key differences for registering a Medical Device including Digital technologies in Europe and in the US? How to establish an optimal strategy for placing on the market of these disruptive medical products on both sides of the Atlantic? How to capitalize on the regulatory efforts invested in a CE marking to subsequently obtain an US FDA clearance?
Date: Thursday September 23th from 9am to 10am
Location: Online, Sign up for one or for both workshops here!.
2. Introduction to Medical Device Software development
This workshop will give you a better appreciation of Medical devices Software, why safety and efficacy of software is important to regulators. It will also introduce you to key regulations and standards for software including both the MDR and IVDR as well as IEC62304 software lifecycle processes, ISO14971.
Date: Tuesday September 28th from 9am to 10am
Location: Online, Sign up for one or for both workshops here!.
About the company
Voisin Consulting Life Sciences is a global product development consulting firm, which guides Biotechnology, Pharmaceutical and MedTech manufacturers throughout product development and market access. From early stage to patients, they assist innovators by designing product development strategies that optimize clinical development to drive commercial success.
The zoom link for the event will be sent to you the day before the event.
The event is free of charge.
Looking forward to seeing you there!
The Geneus Team
Events