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VCLS Neighborhood event-eHealth

How to obtain a market approval for a health tech application or a software?

Agenda

18 h – 18 h 30: Welcome
18 h 30 – 19 h: Presentation from David Sainati, Founder & President of MedappCare
19 h – 19 h 30: Presentation from Jean-Bernard Chauvin, CEO of green medical software
19 h 30 – 21 h: Networking

Talk #1: Best practices while developing a mobile health application

Spoken language: french

Faced with the constant increase in the number of mobile health applications in the world, quality is today an important axis of differentiation for the players in this market. David SAINATI, Founder of Medappcare, the certifying body in connected health, will talk about good sector practices illustrated by concrete examples around cybersecurity, the protection of personal data, ergonomics and the quality of content.

David SAINATI, PharmD., French
Doctor of Pharmacy and graduated in Entrepreneurship at HEC Paris, David Sainati is the founder and CEO of Medappcare. He was expert for European Commission about mHealth and participates to prospective initiatives about regulation in France. With his experience in pharmacies, hospital and in the pharmaceutical industry, David Sainati has identified the need to properly assist patients and healthcare professionals in their choice of mobile health applications. Thus he creates Medappcare, a company specialized in the evaluation and certification of mhealth applications and websites.

 

Talk #2: Why should we anticipate the development process of a medical device software?

Spoken language: french

 

Facing all type of challenges during the development and commercialization of your medical device software, you will find out how an early, highly operational application of medical development standards is so strategic for your company.

Jean-Bernard CHAUVIN has 20 years of worldwide experience in the development of medical device software, including CE marking and FDA 510k dossier filing. Since 2011, Jean-Bernard is the co-founder of KIDITIC Competence Center and works as a team on good practices related to software publishing processes for the BioMedical sector. He brings his know-how and his experience in the operational implementation of standards IEC 62304, ISO 14971, IEC 62366.