How to Select Off-The-Shelf Software for Your Medical Devices While Avoiding Common OTS Pitfalls and Meeting the FDA's Guidelines

Instructor: Stan Magee
Product ID: 700100

recorded version

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Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Oct-2007

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Read Frequently Asked Questions

20 Questions that should be asked by project management during preliminary design of the product for each OTS component to insure that the company is on a prudent path for selection of OTS components.


Off-the Shelf (OTS) software is often incorporated into medical devices as the use of general-purpose computer hardware becomes more prevalent.

The use of OTS (Off- The Shelf) software in medical devices allows manufacturers to concentrate on the product-specific to reduce overall product cost. However there is danger in selecting inappropriate OTS software for use with devices that can increase product risk, at times even to a level above that which is acceptable to the FDA. This course will cover the 20 questions that should be asked by project management during preliminary design of the product for each OTS component to insure that the company is on a prudent path for selection of OTS components. A segment of this presentation covers common pitfalls users have experienced in using OTS components.

In 1990 many questions arose in IDE, 510K, and PMA submissions regarding OTS issues. In 1999 the FDA published a guidance document on OTS. This presentation covers that document in depth, and covers the issues of adequate control and documentation of OTS software used in medical device systems. It also outlines a disciplined method for evaluating and documenting OTS software. Lastly, the presentation addresses system and software aspects of OTS, risk-based validation, validation of OTS, change control and revalidation, and validation documentation

Areas Covered in the seminar:
  • FDA Definition of OTS software
  • Types of OTS software
  • What is minor, moderate and major level of concern?
  • The approach to use when evaluating OTS software
  • The steps required to meet the FDA guidelines for the use of OTS software
  • Documentation required by the FDA
What attendees will learn:
  • Questions to ask in the selection of OTS software.
  • Major pitfalls in using OTS software
  • FDA definition of OTS software
  • FDA major tenets in using OTS software
  • Common types of OTS software used by medical devices' companies
  • The steps required to evaluate OTS software from a hazard analysis standpoint
  • The FDA's hazard analysis and mitigation process for OTS software
  • Basic and special documentation required for OTS software
Who should attend:
This seminar will provide valuable assistance to all medical device companies that use or would like to use OTS software in their devices. Individuals who will benefit include:
  • Project Managers
  • Software Managers
  • Software architects
  • Software engineers
  • Software test engineers
  • V&V personnel
  • R&D engineers
  • Software buyers
  • Documentation experts
  • Quality Assurance experts
  • Regulatory affairs
  • Risk analysis expert

Instructor Profile
Stan Magee is president of Software Engineering Process Technology Company, a firm specializing in the implementation of software process technology for U.S. and international corporations and organizations. Mr. Magee is past convener (1999-2002) of WG 7 (Life Cycle Management) for ISO/IEC JTC1 SC 7 (Systems and Software Engineering) standards group. During his tenure the standard ISO/IEC Standard 15288-System Engineering-System Life Cycle Processes, was developed.

He was a U.S. delegate to the International Plenary meetings from 1986 -- 2002. In 1995 he was elected to the IEEE Computer Society Golden Core of 500 people who have significantly served the IEEE Society in standards development over its 50 year history. Mr. Magee is co-author of the books, Guide to Software Engineering Standards and Specifications, Artech House Publishers, 1997, ISBN 0-89006-919-0 and Guide to Standards and Specifications for Designing Web Software, 1998, Artech House Publishers ISBN 0-89006-819-4. He has authored many technical reports relating to software engineering standards issues. In 1997 Mr. Magee was part of a “People to People” quality mission to China and lectured at Shanghai University on software quality standards. He gives seminars on meeting the requirements of ISO 9001/90003 for medical device firms. In 1994 he established a software business and quality system plan, for VNIPI Sport of Moscow, Russia for obtaining ISO 9001 certification. VNIPI is the privatized MIS section of the Russian Olympic Committee. In 2002, Mr. Magee established a plan for the Thailand Government to be in the upper quartile producers of software in the world market place by 2010. Mr. Magee has over 42 years experience in the software field and is considered an expert in the area of software life cycle methodology.

Mr. Magee holds BS from the School of Engineering from Oregon State University and an MBA in International Business from the University of Puget Sound.

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