Many medical device manufacturers have difficulty developing software in compliance with an array of regulations and standards including: FDA QSR, ISO 14971, and AAMI SW 68. The difficulty often is a lack of understanding how to interpret and apply the regulations to software in a manner that is both reasonable and compliant. This workshop provides practical guidance and suggestions for developing software that complies with the regulations in a cost-effective manner.

Pertinent regulations are reviewed and interpreted from the perspective of software development. In addition, the following topic areas will be discussed in depth: Software Development Process, Software Validation, Risk Management, and Software Configuration Management. An interactive exercise is included to reinforce the importance and value of Risk Management for devices that contain software.

Audience:

Quality Managers, software process and quality professionals, software engineers, and project managers who need reasonable software development procedures that comply with the required standards and regulations.

Outline:

• Overview of FDA Quality System Regulation, International Standards and related Guidance Documents

• Quality System Overview

• Interpreting the Regulations for Software Development

• Software Development Process

• Software Validation

• Risk Management

• Risk Management Exercise

• Software Configuration Management

• Summary

• Action Plan

Speaker Bio:

Steven R. Rakitin has 30 years experience as a software engineer and software quality manager in a broad range of industries. He has written several papers on the subject of software quality and published a book titled: Software Verification & Validation for Practitioners and Managers. He was a member of the Working Group that produced the first IEEE Standard for Software Quality Assurance Plans (IEEE-STD-730). He is currently serving on the IEEE Standard 1012 (Verification & Validation) Working Group. He received a BSEE from Northeastern University and an MSCS from Rensselaer Polytechnic Institute. He has earned certifications from the American Society for Quality (ASQ) as a Software Quality Engineer (CSQE) and Quality Auditor (CQA). He is a member of the IEEE Computer Society, the ASQ Software Division, and is on the Editorial Review Board for the ASQ Journal Software Quality Professional. He presents tutorials and workshops at conferences worldwide. As President of Software Quality Consulting Inc., he helps companies establish a more predictable software development process. His web site is www.swqual.com

Registration fee includes comprehensive course notes, lunch and coffee breaks.

Decision/Cancel Date for this course is Tuesday, April 3, 2007

Course Fee Schedule:

On-line Registration and Payment

On-line registration is closed for this course, but registration is still available on-site between 8:00AM – 8:30AM April 11, 2007 at the Holiday Inn Select, 15 Middlesex Canal Park, Woburn or by contacting the office at 781-245-5405.

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Updated Thursday August 16, 2007