How to obtain a market approval for a healthtech application or a software
jeu. 4 octobre à 18:00
18:00 Warm welcome 18:30-19:00:
Speaker 1: David Sainati, CEO MedappCare (Conference in french)
Speaker 2: Jean-Bernard Chauvin, Co-Funder Green Medical software (Conference in french)
Active networking, Drink & Snack Sharing Details:
Speaker 1: David Sainati (Conference in french) Title:
Develop a mobile health app: best practices Abstract:
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. Medappcare, the certifying body in connected health, will present good sector practices illustrated by concrete examples around cybersecurity, the protection of personal data, ergonomics and the quality of content Short Pen Portrait : David SAINATI, PharmD., French.
Doctor of Pharmacy and gratuated 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. Speaker 2: Jean-Bernard Chauvin. Title:
Why should we anticipate the development process of a medical device software? Subject:
To face the challenges of the good development of your medical device software, and its marketing, you will discover how an early, highly operational application of medical development standards is so strategic for your company. Short Pen Portrait :
Mr. Jean-Bernard CHAUVIN has 20 years of experience in the development of medical device software marketed around the world (including CE marking and FDA 510k dossier filing).
Since 2011, Mr. Jean-Bernard CHAUVIN is the co-founder of the KIDITIC Competence Center and works as a team on good practices related to software publishing processes, mainly for the BioMedical sector. Most of the missions revolve around software aspects of devices (active DM, DM DIV, eHealth, iOT, etc.). Mr. Jean-Bernard CHAUVIN brings his know-how and his experience in the operational implementation of standards IEC 62304, ISO 14971, IEC 62366.
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