Software Development for Medical Device Manufacturers – On-Line Course

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Software Development for Medical Device Manufacturers

You will have 90 days to access this on-line course.

Course Description

This course provides an introduction to the development of medical device software. The course is comprised of 4 modules that range from 30-45 minutes in duration. The focus is on complying with FDA Design Controls and IEC 62304 requirements.

This course is intended for software developers who are actively involved in developing medical device software.

Module 1
• Medical Device Definitions: FDA and European Union (EU)
• Regulatory Roadmap
• FDA/EU Device Classifications
• FDA QSR Regulation
• FDA Guidance Documents that pertain to medical device software

Module 2
• International Standards that pertain to medical device software
• Types of Software Regulated by FDA
• Quality System basics: Procedures, Work Instructions and Records
• ALL Software is Defective…

Module 3:
• Design Control Overview
• General Requirements
• Design and Development Planning
• Software Development Models
• Design Input
• About Requirements…
• Design Output
• Design Reviews

Module 4:
• Design Control (continued)
• Design Verification
• Software Verification Process
• Testing Overview
• Design Validation
• Software Validation Process
• Design Changes
• Design Transfer
• Design History File
• Course Summary

Speaker Bio:

Steven R. Rakitin has over 40 years experience as a software engineer including 25 years of experience in the medical device industry. He has worked with over 85 medical device manufacturers worldwide, from startups to Fortune 100 corporations. He has written several papers on medical device 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 Senior Life 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.

Course Fee Schedule: Registration is On-Going

Cost: $125