Seminar · Berlin, Germany
2-day In-person Seminar on “Applying ISO14971:2012 and IEC62304
Medicine · Pharmaceuticals · Management
Key numbers
- Editions on record
- 1first in 2014
About 2-day In-person Seminar on “Applying ISO14971:2012 and IEC62304
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
Meet your Expert:
Markus Weber is owner and Principal Consultant with System Safety, Inc. He specializes in safety engineering and risk management for critical medical devices. He graduated from Ruhr University in Bochum, Germany with a MS in Electrical Engineering. Before founding his consulting company, he was a software safety engineer for the German approval ag
From our listing of this edition. Details may have changed since.
Editions
| Year | Dates | Where | Exhibitors | Visitors |
|---|---|---|---|---|
| 2014 | 23–24 Oct 2014 | Hilton Berlin Berlin, Germany | — | — |
Past editions from the bvents archive (2008–2019) and organiser figures where they were published.
Questions
When is 2-day In-person Seminar on “Applying ISO14971:2012 and IEC62304?
The next dates haven't been confirmed. The last edition we have on record was 23–24 Oct 2014.
Where is it held?
The last edition we have was at Hilton Berlin, Berlin, Germany.