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.
$2,177.00
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16 hours
Combination lecture and classroom exercises
Available on-site at Quality Support Group Facilities
Start date: April 07, 2025
End date: April 08, 2025
Start time: 08:30 a.m. EST
End time: 04:30 p.m. EST
Venue: Quality Support Group Facilities
Directions: Training located at Quality Support Group, 319 Littleton Rd STE 206, Westford, MA 01886. Please plan to arrive 15 minutes prior to the training session start time.
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.
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/EU regulations and international standards. This course is also appropriate for people who are new to the medical device industry. Extensive reference documents are available by requesting a DropBox link.
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.
Design and Development Processes
The course begins with the Regulatory Roadmap that device manufacturers are expected to navigate. The Design and Development process outlined in both the FDA QSR and in the new QMSR (ISO 13485 Section 7.3) are discussed in detail along with corresponding requirements from IEC 62304 Medical Device Software Lifecycle Processes. Woven into the discussion of Design and Development are numerous examples of Best Practices.
Topics covered include:
Safety and Security Risk Management
The similarities and differences between Safety Risk Management (ISO 14971) and Security Risk Management (AAMI SW 96) are discussed. Security Risk Management is based on the Risk Management framework defined in ISO 14971 but is focused on establishing a Secure Product Development Framework to minimize the risk of cybersecurity events. FDA and EU Guidance documents are discussed along with AAMI Principles for Medical Device Security – Risk Management TIR 57. Extensive references and examples of Best Practices are included.
Topics covered include:
Safety Risk Management Process as defined by ISO 14971:2019
Security Risk Management Process as defined by ANSI/AAMI SW96:2023, TIR 57:2016 2023, FDA and EU Guidance documents
Additional Resources
The following additional resources are included in the course notes:
Reference Documents
An extensive set of reference documents are provided in a DropBox folder upon request. These documents include:
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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