2-day In-person Seminar on “Applying ISO14971:2012 and IEC62304 - A Guide to Practical Risk Management” in Berlin, Germany

A Guide to Practical Risk Management

23 24 October 2014

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Summary of the Workshop:
Gaps, incorrect or incomplete implementation of safety functionality can delay or make the certification/approval of medical products impossible. Most activities cannot be retroactively performed since they are closely linked into the development lifecycle. Diligent, complete and correct implementation of risk management from the start of product development is therefore imperative. This course will introduce all necessary steps to design, implement and test critical medical devices in a regulatory compliant environment. This course will additionally address the software risk management and the resulting interfaces to device level risk management.

To comprehensively summarize all risk related activities and to demonstrate the safe properties of a device the 'Safety Case' or 'Assurance Case' document is a well-established method to collect all safety related information together in one place. This documentation will most likely become mandatory for all devices (currently only required for FDA infusion pump submissions). This course will introduce the basic concepts and content of safety assurance cases and will illustrate the usefulness for internal and external review of safety related information.

Learning Objectives:
Introduction into Risk Management and Quality System Integration
Risk Management to ISO 14971:2012
Usability and Risk Management
Software Risk Management (IEC62304 / FDA software reviewers' guidance)
Software Risk Management (IEC62304 / FDA software reviewers' guidance)
Safety / Assurance case

RAC Credits: 12
Date: October 23rd & 24th, 2014
Event Details: http://bit.ly/XzsbJC
Location: Berlin, Germany
Venue: Hilton Hotel Berlin, Mohrenstra 30 10117 Berlin Germany
Venue Link: http://www3.hilton.com/en/hotels...
Registration: Open Enrollment
Delivery: Face-to-Face event
Until September 15, Early Bird Price: $1,595.00
From September 16 to October 21, Regular Price: $1,795.00

1 speaker

2 sessions

Workshop Day 1 from 9am to 6pm Thursday 23rd October 2014

Workshop Day 2 from 9am to 6pm Friday 24th October 2014

Hilton Berlin

Germany Germany / Berlin

Mohrenstrasse 30, Berlin, 10117

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2 known attendees

  • Markus Weber
  • GlobalCompliancePanel

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