Innovation Event

Overview

Category: Medtech

Place: Switzerland Innovation Park Basel Area AG, Gewerbestrasse 24, 4123 Allschwil

Adrian Sprenger

Your contact person

Adrian Sprenger

Dr. | Project Manager Entrepreneurship, Medtech


Tel. +41 61 295 50 23

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

17.07.2018

How to develop medical device software that conforms to IEC 62304

FULLY BOOKED

 

Medical apps can facilitate physician’s decision, diagnose symptoms, or give suggestion to treatment. The International Electrotechnical Commission created the IEC 62304 standard which outlines the requirements for medical device software life cycle processes. This standard can be used for Medical Apps or software embedded in Medical Devices. The compliance to this standard is mandatory in order to meet the relevant essential requirements in Annex I of the EU directive MDD 93/42/EEC. Developing medical device software according to this standard helps manufacturers to achieve one of the important steps in order to get the product to EU markets.


In this workshop the audience will learn:

  • IEC 62304 and relation to regulatory requirements
  • Software safety class and its impact to development activities and documentation
  • Key points of the software life cycle processes for medical device software
    • Software development process
    • Software maintenance process
    • Software risk management process
    • Software configuration management process
    • Software problem resolution process

 
Date: 17.07.2018, 13:30 - 15:30
Location: Switzerland Innovation Park Basel Area, Gewerbestrasse 24, 4123 Allschwil
 
Program

13:30 Presentation
15:00 Q&A Session
15:30 Apéro
16:00 Ende

 
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 (REGISTRATION CLOSED). 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.
 
He has over 7-year 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, he 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 creation of Technical Documentation. He focuses on 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 participant in various software working groups (DKE, VDI).
 
 

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