Software Development for Medical Device Manufacturers An Intensive Two -day Workshop – Spring 2015
15 Middlesex Canal Park Drive
Woburn, MA 01801
USA
Speaker: Steve Rakitin, President, Software Quality Consulting
Dates: March 25-26 8:30-4:30
Decision (Run/Cancel) Date for this Courses is Wednesday, March 11, 2015
Payment received by March 9
IEEE Members $465
Non-members $495
Payment received after March 9
IEEE Members $495
Non-members $545
Developing software in compliance with FDA QSR regulation, guidance documents and international standards can be challenging. This two-day intensive course provides your organization with a clear understanding of what FDA requires for software-based medical devices. The course applies to all software-based medical devices – from traditional devices to mobile medical apps. We will discuss recent FDA guidance documents on mobile devices and cyber-security – which is now required for all software-based device submissions.
The focus of this course is interpreting Design Controls for Software. Each section of the Design Controls regulation (820.30) is discussed from the perspective of software. Discussions on critical topics such as Requirements, Design Reviews, Software Verification & Validation and Risk Management are included. In addition, requirements for validating software development tools and software used in Manufacturing and Quality Systems are also discussed.
Interactive group exercises are included to facilitate discussion and learning.
WHO SHOULD ATTEND
Software engineers, project managers, quality managers, software quality professionals, and anyone who needs to develop cost-effective processes and procedures that will enable their organizations to deliver high quality software-based medical devices that comply with the international standards and FDA regulations and guidance documents.
COURSE OUTLINE
• Introduction
– FDA Regulations: 21 CFR Part 820 (QSR) and 21 CFR Part 11
– FDA Guidance Documents for Software
– International Standards and Technical Reports
– Types of Medical Device Software
– Procedures, Work Instructions and Records
• Interpreting Design Controls for Software
– Software Development Models
– Design and Development Planning
– Design Inputs
• About Requirements…
• Requirements Exercise
– Design Outputs
– Design Reviews
– Design Verification
• Software Verification Process
• Testing Overview
– Design Validation
• Software Validation Process
• Validation Exercise
– Design Changes
– Design Transfer
– Design History File
• Validation of…
– Software Tools used to develop Device Software
– Software used in Manufacturing
– Software used in Quality Systems
• Risk Management
– Standards and Regulations
– Terms and Concepts
– Risk Management Process
– Risk Management Tools and Techniques
• Fault Tree Exercise
– Data Collection and Analysis
– Documentation Requirements
• Summary
• Comprehensive References Provided
Speaker Bio:
Steven R. Rakitin has over 35 years experience as a software engineer and software quality manager. He has written extensively on the subject of software quality and published a book titled Software Verification & Validation for Practitioners and Managers, 2nd Ed. He has also published the following papers on medical device software safety risk management:
“Networked Medical Devices: Essential Collaboration for Improved Safety”, AAMI Biomedical Instrumentation & Technology, vol.43, no. 4, pp. 332-338, July-August 2009.
“Coping with Defective Software in Medical Devices”, IEEE Computer, vol. 39, no. 4, pp. 40-45, April 2006.
He has worked on several IEEE Software Engineering standards committees and is a member of the AAMI HIMSS CE-IT Collaboration team. As a member of an AAMI/FDA committee, he helped write the Recommended Practice for the Application of quality management system concepts to medical device data systems, AAMI SW87:2012.
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, ASQ Software Division, ASQ Biomedical Division, and the Association for the Advancement of Medical Instrumentation (AAMI), and the Massachusetts Medical Device Industry Council (MassMEDIC). He is on the Editorial Review Board for the ASQ Journal Software Quality Professional. He has presented invited papers and tutorials at conferences worldwide for the Health Industry Manufacturers Association, AAMI, ASQ, and IEEE.
As president of Software Quality Consulting Inc. (www.swqual.com), he helps medical device manufacturers comply with regulations and standards for software. He has worked with over 75 medical device manufacturers including startups through Fortune 500 companies. He can be reached at steve@swqual.com.