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IEC 62304 for Medical Device Software Development: Steps to Compliance - Webinar By GlobalCompliancePanel

Date: 19-Jul-12 to 19-Jul-12
Location: Online Training / Wilmington / Delaware / United States
Category: Healthcare & Pharmaceuticals Conferences & Trade Fairs

Overview: IEC62304 is a internationally recognized software lifecycle standard. The risk dependent activities and documentation requirements necessary for compliance with this document will be explained.

Questions like:
How much detail is required in the requirement specification?
What is a software unit?
How can integration testing be performed without test harnesses?
will be answered. Practical guidance on how to employ a streamlined but yet compliant development process will be given.

Why should you attend: 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 streamline the development process and minimize the regulatory burden.

Areas Covered in the Session:
Software requirements specification
How to write meaningful requirements
Software architectures
Multi software system implementation
Software design documentation
Requirements traceability
Software unit and integration testing
Software testing in real-time systems
Software tools
SOUP (software of unknown providence)


Webinar By GlobalCompliancePanel

Price List:
Live : $245.00
Corporate live : $495.00
Recorded : $295.00

Phone: 800-447-9407
Fax: 302-288-6884

webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com

Visitors

Project Management
Regulatory / Quality Control
Software Engineering

Exhibitors

Markus Weber, Principal Consultant with System Safety, Inc., 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 System Safety, Inc., he was a software safety engineer for the German approval agency, TUV. Since 1991, Mr. Weber has been a leading consultant to the medical device industry on safety and regulatory compliance issues, specifically for active and software-controlled devices. In conjunction with the FDA, he has published works on risk management issues and software-related risk mitigations. Mr. Weber has helped multiple companies, from startups to Fortune 500 firms.

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