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Kategorie: Medtech

Ort: Messeturm Basel

Adrian Sprenger

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Adrian Sprenger

Dr. | Manager Entrepreneurship


Tel. +41 61 295 50 23

adrian.notexisting@nodomain.comsprenger@baselarea.notexisting@nodomain.comswiss
event Medtech

04.06.2019

Medical Device Software: A regulatory insight into safety and security

This talk focuses on two important aspects of medical device software: safety and security. Whereas safety has long been a focus of medical devices and is reflected in many harmonized standards, security in medical devices has not yet been thoroughly discussed. The EU Medical Device Regulation (MDR), which became effective in May 2017 contains explicit essential requirements regarding to cybersecurity for medical devices. However, up until now, there is no harmonized standard regarding cybersecurity for medical devices.

In the first part, the talk will present the key points in establishing software life-cycle processes according to IEC 62304 whose goal it is to ensure safety and effectiveness of a medical device. The second part of the talk will focus on how to handle cybersecurity for medical devices and which other regulatory aspects have to be taken into consideration.


When: 04.06.2019, 13:00 - 15:00
Where: Messeturm Basel, Messeplatz 12, 4058 Basel

 
Program

13:00 Presentation
14:15 Q&A Session
15:00 Coffee Break
15:30 End

 
Registration and Cancellation
Participation to the event is free of charge; however, your registration is mandatory. Please use this link to register for the seminar. If the seminar is overbooked, we only admit one person per company. Registration will be confirmed or declined one week prior to the event. In case you later find you cannot attend, please kindly use the link in the registration confirmation sent to you by email to cancel your registration and free your spot for someone else.
 
Startup projects are preferred
If applicable, please include a short description of the project for which you would like to attend the seminar. As the economic promotion of the Basel area, we specifically support startup projects from the region with our free seminars and workshops. Hence, startup projects from Basel-Stadt, Basel-Landschaft and Jura are handled with priority, remaining seats are given to all other registrations according to registration date.
 
About the Speaker
Ittipan Kanluan is a Regulatory Affairs Expert in the field of Active Medical Devices / Medical Software at CE plus GmbH, an international service provider for medical devices and in vitro diagnostics based in Germany. Ittipan has over 7 years experience in the medical device industry. After graduating with an engineering degree, he worked as a software engineer with a medical device manufacturer. He was responsible for developing software components for a high-risk medical device. He gained in-depth experience in product development, software life cycle process, requirements engineering, risk management, and technology implementation.

At CE plus, Ittipan is responsible for Active Medical Devices and Medical Software. He provides consulting to clients in regulatory process for CE-marking in compliance with EU Directives 93/42/EEC. He assists medical device manufacturers in product classification, selection of suitable procedures for conformity assessment, gap analysis, and in creating technical documentation. His strong focuses are in the software life cycle processes according to IEC 62304, risk management according to EN ISO 14971, usability engineering according to IEC 62366, and requirements engineering. Ittipan is a member and participate in various software working groups (DKE, VDI).

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