Participants will learn 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: FDA QSR, QMSR, EU MDR, ISO 13485, IEC 62304, ISO 14971, AAMI SW 96, IEC 62366-1.
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Please contact us if you are interested in private training for this workshop.
16 hours
This course will be presented with a live instructor using interactive web-meeting software.
Course notes and access to an extensive collection of reference documents are provided.
The regulatory landscape for medical device software development is changing dramatically. Beginning in February 2026, device manufacturers must comply with the new FDA Quality Management System Regulation (QMSR) which is based on the ISO 13485 Medical Device Quality Management System Standard. In addition, a recently adopted standard for security risk management (AAMI SW96) adds additional requirements for cybersecurity.
This course provides insight into these changes as well as requirements for safety risk management as defined in ISO 14971 Medical Device Risk Management and IEC 62304 Medical Device Software – Software Life Cycle Process. Also discussed is IEC 62366-1 Medical Devices – Application of Usability Engineering.
This intensive two-day course reflects both current FDA regulations as well as the new FDA QMSR due to take effect in February 2026.
This course is intended for software engineers, project managers, quality managers, software quality professionals, RA/QA staff, and anyone who is interested in learning about 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 and access to an extensive collection of reference documents are provided.
Through training participants will learn 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.
The course content will be covered in 2 full-day sessions as outlined below. Sessions will be from 8am-5pm ET with two short breaks and a half-hour lunch break.
DAY 1 – Medical Device Software Design and Development
Duration ~8 hours
8am-5pm ET
This session will cover key regulatory requirements for medical device software in the US and EU as well as corresponding software development requirements from IEC 62304
DAY 2 – RISK MANAGEMENT, WRITING SOFTWARE REQUIREMENTS AND TOOL VALIDATION
Duration ~8 hours
8am–5pm ET
The morning session will cover key regulatory requirements for both Safety and Security Risk Management. Newly adopted requirements for Safety and Security Risk Management are discussed along with relevant international standards and guidance documents.
The afternoon session will cover the challenges of writing requirements for software and will discuss alternative methods for expressing requirements. The session will conclude with a discussion of Tool Validation including software development tools and software tools used in Manufacturing and QMS.
RISK MANAGEMENT OVERVIEW
Safety Risk Management Process as defined by ISO 14971:2019
Summary and Q&A
Security Risk Management Process as defined by ANSI/AAMI SW96:2023, TIR 57:2016 2023, FDA and EU Guidance documents
Summary and Q&A
APPENDIX
WRITING REQUIREMENTS FOR MEDICAL DEVICE SOFTWARE
Introduction
Challenges Expressing Requirements
Techniques to Reduce Ambiguity
Summary and Q&A
TOOL VALIDATION – Software Development Tools, Software used in Manufacturing and QMS
Regulatory Requirements
Validation Approach for Validation of:
Summary and Q&A
Chris, Angelo and Barbara,
The recent meeting “What we can learn from FDA Warning Letter” was an excellent and exactly what I was looking for. Please keep me on the list for future meetings. Real professional of you folks. I have given your companies information out to an acquaintance from ASQ as a source for training for internal auditing. Looking forward to a long relationship with your team.
Hi Angelo,
Great ISO 13485:2016 Internal Auditing class, honestly the most well run and informative class I’ve taken.
Hi Angelo,
We are satisfied with the process and the report. Gordon does a good job! He is up on the regulations and what we need to focus on. I have found in past years what he points out is what comes up on the radar with the Notified Body. It helps us to be ready for the process.
Thanks for letting us know!
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