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Software Development under Health Regulations for Medical Devices

 

Neighborhood invites you to join our numerous panels around the topic of Medical Devices to better understand the technicalities around its development process.
Our goal is to bring experienced and knowledgeable people on stage to share their thoughts with the audience so you can improve your own product development.

Multiple topics were addressed, such as how to tackle Agile methods for Medical Device development, in which way to uniformize your software regarding international regulatory policies (both in the US and Europe), how to incorporate the usual norms into your product development and what is the impact of AI.

Keynote#1: Agile Methods for Medical Device Development

Tom Dubin
CTO, HILLO
Former mobile developer then Technical Lead in different start-ups. Tom graduated from Ensicaen with an engineering degree. Tom is the CTO of Hillo since 2018. Hillo develops artificial intelligence, which learns from patients with diabetes’ habits and physiology and is able to reproduce each patient’s glycemic response, predict blood glucose trends at more than 2 hours and provide real-time personalized therapeutic advice.

 

Keynote#2: Compliance with International Regulatory Policies (Software Europe et US)

Gaëlle Salaün
RAQA Manager, CARDIOLOGS
Gaëlle is responsible of the Regulatory and Quality assurance activities at Cardiologs since 2 years. Before Cardiologs, she worked for a couple of international medical device companies and has transitioned to work with innovative start-ups since 2014. Gaëlle holds a degree in Biomedical Engineering and Health from ISIFC, a school specialised in medical devices that possess a triple culture: technical, regulatory and medical. Founded in 2014, Cardiologs is a Medtech start-up engaged in cardiac diagnostics transformation using medical grade artificial intelligence and cloud technology.

 

Round Table: Integration of the different norms ISO 62304, ISO 13485 to your product including AI.

Stéphanie Trang
Managing Director, AI for Health
Stephanie has a consulting & financial background (7 years, ex PwC business modeling and valuation, ex Capgemini Consulting chief of staff) as well as entrepreneurial’s experiences (3 years as a CEO/CFO and startups consultants). She knows about “Big” company’s culture as well as the startup’s mindsets. She creates links between both organisations through Open Innovation and Intrapreneurship programs.

 

Caroline Florequin
Head of Regulatory Affairs, Implicity
Biomedical engineer graduated from the ISIFC. Caroline worked for companies with class I sterile devices as quality and regulatory affairs officer, and as a quality officer for a consulting company. Coraline is in charge of quality and regulatory affairs in Implicity since 2 years.

 

David GAUTIER, PhD
Co-Founder & COO, CIBILTECH
Former consultants for different IT companies, David has a scientific background with his PhD received at Institut Pasteur on immuno-modulation. David is the co-founder and COO of Cibiltech. Cibiltech develops digital solutions for predictive medicine in renal transplantation. Our AI-based algorithm helps nephrologists to better assess individual graft loss trajectories for each patient and to adjust treatment accordingly.