Software Development for Medical Device Manufacturers – Spring 2016
15 Middlesex Canal Park Dr
Woburn, MA 01801
USA
Wednesday, March 30 and Thursday, March 31
Decision (Run/Cancel) Date for this Course is March 21,2016
Payment received by March 17
IEEE Members $465
Non-members $495
Payment received after March 17
IEEE Members $495
Non-members $545
Phone 781-245-5405
email sec.boston@ieee.org
Fax 781-245-5406
Make Checks payable to:
IEEE Boston Section
One Centre Street, Suite 203
Wakefield, MA 01880
An Intensive two-day course
Speaker/Instructor: Steve Rakitin, Quality Software Consulting
Developing software in compliance with FDA, EU regulations and international standards is challenging. This two-day intensive course provides practical guidance and suggestions for developing software that complies with applicable FDA and EU regulations, guidance documents and international standards such as IEC 62304 and ISO 14971. The focus of this course is interpreting Design Controls for software. Each section of the Design Controls regulation (820.30) is discussed from the software perspective. Corresponding requirements from IEC 62304 are woven into the flow.
In-depth discussion of critical topics such as Requirements, Software Verification & Validation, Risk Management and Fault Tree Analysis are included. In addition, techniques 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 and firmware engineers, software managers, RA/QA staff, validation engineers, and project managers. Anyone interested in learning how to develop medical device software in compliance with regulations, standards and guidance documents.
COURSE OUTLINE
• Introduction
– Medical Device Definitions – FDA and EU
– Regulatory Roadmap and FDA/EU Device Classification Schemes
– FDA Regulations and Guidance Documents for Software
– Standards – ISO 13485, IEC 62304, ISO 14971, EN-14971, IEC 60601, and IEC 62366-1
– All Software is Defective
• 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 Techniques
– Design Validation
• Software Validation Process
• Validation Exercise
– Design Transfer
– Design Changes
– Design History File
• Validation of…
– Software Tools used to develop Medical 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 reference materials included
Speaker Bio: Steven R. Rakitin has over 40 years experience as a software engineer and software quality manager. He helped write the first IEEE Software Engineering Standard (IEEE-STD-730 Standard for Software Quality Assurance Plans) as well as the current revision IEEE 730-2014. He is also a member of the working group writing IEEE Standard 1012 (System Verification & Validation). He has written several papers on medical software risk management as well as a book titled: Software Verification & Validation for Practitioners and Managers.
He received a BSEE from Northeastern University and an MSCS from Rensselaer Polytechnic Institute. He earned certifications from the American Society for Quality (ASQ) as a Software Quality Engineer (CSQE) and Quality Auditor (CQA). He is a Life Senior member of IEEE and a member of MassMEDIC.
He is on the Editorial Review Board for the ASQ Journal Software Quality Professional.
As President of Software Quality Consulting Inc., he helps medical device companies comply with FDA regulations, guidance documents, and international standards in an efficient and cost-effective manner.