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PRODID:-//Journal of Medical Device Regulation - ECPv4.9.3.2//NONSGML v1.0//EN
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X-WR-CALNAME:Journal of Medical Device Regulation
X-ORIGINAL-URL:https://globalregulatorypress.com
X-WR-CALDESC:Events for Journal of Medical Device Regulation
BEGIN:VEVENT
DTSTART;TZID=Europe/London:20201117T090000
DTEND;TZID=Europe/London:20201119T170000
DTSTAMP:20260725T173524
CREATED:20201029T114351Z
LAST-MODIFIED:20201029T114505Z
UID:12695-1605603600-1605805200@globalregulatorypress.com
SUMMARY:Medical Device Software: Complying with the MDR & FDA Regulations Training Course
DESCRIPTION:Location: Online webinar \nDescription: This intensive three-day course provides a comprehensive appraisal of the regulations and requirements that apply to medical device software worldwide. The programme will be highly interactive\, using real-life examples and state-of-the-art practices identified by Notified Bodies in Europe. There will be in-depth coverage on how to prepare compliant technical file documentation for medical device software products and a review of software specification\, risk management\, architectures\, usability and resulting design documentation. Presentations will also offer practical tips on how to streamline the development process and provide an understanding of the regulatory requirements and how Notified Bodies review technical files. There will be sessions on the practical implication of risk management and usability and an analysis of the differences between FDA guidance and MDR guidance on medical device software. Software recalls\, the use of apps in medical devices\, the implications of the new draft usability standard\, and advice on how to validate your system design will also be addressed. \nOrganiser: Management Forum \nContact: +44 (0)20 7749 4730 \n
URL:https://globalregulatorypress.com/event/medical-device-software-complying-with-the-mdr-fda-regulations-training-course/
ATTACH;FMTTYPE=image/jpeg:https://globalregulatorypress.com/wp-content/uploads/2020/10/software.jpg
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