Dates: November 9 & 10, 2021
Time: TBD – Eastern Time!
WHERE: Web-Based Course with Live Instructor
This course will be presented with a live instructor using web-meeting software. The course content will be covered in 4 sessions presented over four days.
COURSE SUMMARY: Developing software in compliance with the FDA Design Control regulation, changing FDA guidance documents and latest international standards is challenging. This intensive course provides practical solutions and suggestions for developing software in a manner that meets applicable FDA regulations, guidance documents and international standards, such as IEC-62304:2015.
The focus is on interpreting Design Controls for software. Each section of the Design Controls regulation
(820.30) is discussed from the perspective of software development. Discussions
on key topics such as Software Requirements, Traceability, Design Reviews,
Software Verification & Validation and Risk Management (including recently
updated standards ISO-14971:2019 and EN-14971:2019)
are included. Also discussed are FDA requirements for validation of software
development tools and software used in Manufacturing and Quality Systems. Also
discussed are recent FDA Guidance Documents on Cybersecurity, Mobile
Apps, and Usability.
THIS COURSE IS
INTENDED FOR… Software engineers, project managers,
quality managers, software quality professionals, RA/QA staff, 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 FDA regulations and international standards. This course is also
appropriate for people who are new to the medical device industry. Course
notes, access to an extensive collection of reference documents and a training
certificate are provided.
COURSE OUTLINE: This
course will be presented with a live instructor using web-meeting software. The
course content will be covered in 4
sessions as described below.
SESSION 1 – Regulatory Context Duration ~3 hours with one 15 min break
This session will cover key regulatory requirements
for medical device software in the US and EU.
Regulations and Guidance:
FDA Medical Device Regulation (21 CFR Part
820 – specifically, design controls)
EU Medical Device Regulation
FDA Guidance Documents:
Guidance for Content of Pre-market
Submissions for Medical Devices Containing Software
Off-the-Shelf Software Use in Medical Devices
General Principles of Software Validation
Content of Premarket Submissions for
Management of Cybersecurity in Medical Devices
Policy for Software Device Functions and
Mobile Medical Applications
Applying Human Factors and Usability
Engineering to Medical Devices
ISO 13485:2016 Medical Devices – Quality
IEC 62304: 2015 Medical Device Software –
Software Lifecycle Processes
ISO 14971: 2019 Application of Risk
Management to Medical Devices
EN 14971: 2019 Application of Risk Management
to Medical Devices
Off-the-Shelf (OTS) Software and Open Source
Discussion: All Software Is Defective…
SESSION 2 – FDA Design Controls and IEC 62304 – Part 1 Duration ~2.5 hours with one 15 min break
This session will cover FDA Design Controls and IEC
62304 requirements for medical device software.
Design and Development Planning
How does Agile Development fit?
Medical Device Software Lifecycle Processes
o FDA Levels of Concern
o IEC 62304 Software
Removing Ambiguity from Requirements
Architecture and Design
Software Design Changes
SESSION 3 – FDA Design Controls and IEC 62304 – Part 2 Duration ~2.5 hours with one 15 min break
This session will cover Software Verification and
Unit and Integration Testing
Software Validation Testing
SESSION 4 – Software Tool Validation and Risk Management Duration ~2.5 hours with one 15 min break
This session will cover Software Tool Validation
and Risk Management requirements.
Software Tool Validation
tools need to be validated
for software tools
Validation of Manufacturing
Software and Quality System Software
Risk Management Using Fault Tree Analysis
Review of ISO/EN 14971:2019 Requirements
Example of Fault Tree Analysis and Failure
Modes Effect Criticality Analysis (FMECA)
About the instructor…Steven R.
Rakitin has over 45 years experience as a software engineer. He has over 30
years of experience in the medical device industry and has been a medical
device consultant for over 20 years. He has worked with over 100 medical device
manufacturers and biotech companies worldwide, from startups to Fortune 100
corporations. He has published 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.
collaboratively with medical device companies to help them comply with FDA
regulations, guidance documents, and international standards in an efficient
and cost-effective manner.