BEGIN:VCALENDAR
VERSION:2.0
PRODID:-//Memento EPFL//
BEGIN:VEVENT
SUMMARY:Medical Device industry\, the logical step after academia
DTSTART:20171123T173000
DTEND:20171123T193000
DTSTAMP:20260925T073438Z
UID:42587eb9175cb1d02f1464709d2cd4a64e7cc4c023753ffb2f8c94b1
CATEGORIES:Internal trainings
DESCRIPTION:Dr Szymon Kostrzewski\, CTO of KB Medical Kim Rochat\, Senior 
 Partner and Cofounder of Medidee Services SA Dr Wojciech Bobela \, Project
  Associate at Medidee Services SA\nSV PhD Student Association (ADSV) and M
 edidee Services SA have a great pleasure to invite you to the seminar “M
 edical Devices industry\, the logical next step after your studies”. You
  will have a chance to learn about medical device development and complian
 ce\, as well as opportunities of non-academic career paths within regulato
 ry affairs field.\nWhen: 23rd November\, 17h30\nWhere: SV1717\nThe talks w
 ill be followed by an apero where you can discuss informally with the spea
 kers.\nSpeakers and Topics:\n\n	Dr Szymon Kostrzewski\, CTO of KB Medical\
 , “The regulatory journey of a Surgical Robotic system”\n	Kim Rochat\,
  Senior Partner and Cofounder of Medidee Services SA\, “The challenge of
  compliance for medical devices"\n	Dr Wojciech Bobela \, Project Associate
  at Medidee Services SA \, “The life of a scientist outside of academia"
 \n\nProgramme:\n17h Registration\n17h30 Welcome and Introduction\n17h35 Ta
 lks and Q&A\n18h35 Apero\nTalks and BIOs:\nThe challenge of compliance for
  medical devices\n1) The regulatory journey of a Surgical Robotic system\n
 As a Spin-off of the EPFL\, KB Medical has developed the AQrate System\, a
  minimally invasive\, surgical robotic assistance system for a wide range 
 of spinal procedures\, requiring high level of precision and rigidity. KB 
 Medical went through the complete design and validation journey and got cl
 eared for marketing in Europe and started the process in the US. Activitie
 s included clinical investigations\, technical validation\, audits and rev
 iew by Notified Bodies as well as interaction with competent authorities. 
 In 2017\, KB Medical has been acquired by Globus Medical\, a global\, US-b
 ased manufacturer. You want to develop a medical device? This is what you 
 should be prepared for.\n Before founding KB Medical\, Dr Szymon Kostrzew
 ski conducted research at renowned institutions including the Stanford Uni
 versity\, EPFL in Switzerland and the German Aerospace Center DLR. As the 
 CTO of KB Medical\, Dr Kostrzewski led KB Medical R&D team into the techni
 cal and regulatory journey of developing a complex medical device.\n2) The
  challenge of compliance for medical devices\nBefore being able to place a
  medical device on European Market the manufacturer has to comply to numer
 ous legal requirements organized in complex regulations and standards. Wit
 h the current change in regulation\, increased scrutiny on all stakeholder
 s the market seems more like a battlefield rather than an organized econom
 y. Prepared for a true challenge? This is how you can contribute to a grow
 ing economy.\n Kim Rochat is Senior Partner and Cofounder of Medidee Serv
 ices SA. His mission is to support medical devices manufacturer in the con
 stant and most efficient compliance to legal requirements. His activities 
 range from implementation of quality management systems\, regulatory affai
 rs and clinical investigations and evaluations.\n3) The life of a scientis
 t outside of academia\nEvery young scientist during the course of their Ph
 D\, sooner or later will ask themselves at least one of the following ques
 tions… “should I continue my career in academia?”\; “if I choose t
 o quit\, what options do I have?”\; “is my skill set valuable to a pot
 ential employer?”. The world of medical devices offers an exciting\, and
  challenging professional opportunity for scientist who want to be at the 
 front line of technological innovation in the world of medicine. Intereste
 d in the regulatory aspects? This is how your competences make the differe
 nce.\nDr Wojciech Bobela obtained his degree from EPFL\, in the field of N
 euroscience. As a Project Associate at Medidee Services SA\, he provides q
 uality management and clinical support to the medical device manufacturers
 . His activities range from performing clinical evaluations\, designing pr
 otocols and analyzing results of clinical investigations\, as well as impl
 ementation of quality management systems.\n\n\n 
LOCATION:SV 1717 https://plan.epfl.ch/?room==SV%201717
STATUS:CONFIRMED
END:VEVENT
END:VCALENDAR