OVERVIEW: IEC4 IS A INTERNATIONALLY RECOGNIZED 2012 - IEC 62304 for Medical Device Software Development: Steps to Compliance - Webinar By GlobalCompliancePanel

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Category IEC 62304,Medical Device Software Development, software lifecycle standard,requirements specification, integration testing, real-time systems

Deadline: July 19, 2012 | Date: July 19, 2012

Venue/Country: Wilmington, U.S.A

Updated: 2012-06-28 13:21:45 (GMT+9)

Call For Papers - CFP

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)

Who Will Benefit:

Project Management

Regulatory / Quality Control

Software Engineering

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.

Price List:

Live : $245.00

Corporate live : $495.00

Recorded : $295.00

Phone: 800-447-9407

Fax: 302-288-6884

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