IEC 62304 for Medical Device Software Development: Steps to Compliance

Live Webinar on

IEC 62304 for Medical Device Software Development: Steps to
Compliance


Course "IEC 62304 for Medical Device Software Development:
Steps to Compliance" has been pre-approved by RAPS as

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eligible for up to 1.00 credits towards a participant's RAC
recertification upon full completion.
Date & Time:
Instructor Profile:
Thursday, July 19, 2012
10:00 AM PDT | 01:00 PM EDT
Markus Weber
Duration: 60 Minutes
Instructor: Markus Weber
Principal Consultant, System
Safety Inc.
Location: Online
Price : $245.00 (for one participant)
Markus Weber, Principal
Consultant with System Safety, Inc.,
Overview:
specializes in safety engineering and
IEC62304 is a internationally recognized software lifecycle standard.
risk management for critical medical
The risk dependent activities and documentation requirements
devices. He graduated from Ruhr
necessary for compliance with this document will be explained.
University in Bochum, Germany with
a MS in Electrical Engineering.
Before founding System Safety, Inc.,
Questions like:
he was a software safety engineer
for the German approval agency,
TUV. Since 1991, Mr. Weber has
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How much detail is required in the requirement specification?
been a leading consultant to the
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What is a software unit?
medical device industry on safety
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How can integration testing be performed without test
and regulatory compliance issues,
harnesses?
specifically for active and software-
controlled devices. In conjunction
will be answered. Practical guidance on how to employ a streamlined
with the FDA, he has published
works on risk management issues
but yet compliant development process will be given.
and software-related risk
mitigations. Mr. Weber has helped
Why should you attend:

multiple companies, from startups to
Fortune 500 firms. ...more
This webinar will explain basic design control concepts and the
criticality dependent requirements for software development.
Software specification, architectures and resulting design
documentation will be discussed, as well as practical tips on how to
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streamline the development process and minimize the regulatory
Your Necessity is our Priority
burden.
Areas Covered in the Session:
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Software requirements specification

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How to write meaningful requirements
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Software architectures
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Multi software system implementation
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Software design documentation
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Requirements traceability
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Software unit and integration testing
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Software testing in real-time systems
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Software tools
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SOUP (software of unknown providence)
Click here to register for this webinar
Who Will Benefit:
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Project Management
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Regulatory / Quality Control
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Software Engineering
It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely
benefit from this program.
For more information, please contact the event coordinator. We look forward to seeing you at the webinar.
Best regards,
Event-coordinator
GlobalCompliancePanel

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