2025 ASQ Austin March General Meeting

When:  Mar 12, 2025 from 06:00 PM to 08:00 PM (CT)
Associated with  Austin Section
Strengthening Cybersecurity Through Risk Hazard Mapping:
  Integrating DFMEA Feedback into Design Control
Abhinav Singh
Bio: 
Abhinav Singh is a seasoned Software Quality Engineer with over 10 years of experience in medical device manufacturing. His expertise includes regulatory compliance, AI/ML integration, and Software as a Medical Device (SaMD). Abhinav has led validation strategies and system testing for cutting-edge healthcare solutions and implemented processes including agile processes, ensuring compliance with FDA, EU MDR, and ISO standards.  
Summary:
This presentation explores how cybersecurity vulnerabilities can be mapped as risk hazards within DFMEA to identify potential failure modes impacting patient safety and device functionality. The session demonstrates how DFMEA findings can inform design improvements by addressing software and hardware cybersecurity risks early in the development lifecycle. Attendees will gain insights into effective risk assessments, control measures, and feedback loops that reinforce robust design controls while ensuring compliance with regulatory frameworks such as ISO 14971, FDA guidance, and IEC 62443.
Schedule:   
6:00 - 6:20 Section Updates
6:25 – 7:15 Speaker Presentation  
7:20 – 7:35 Q&A  
7:40 – 8:00 Closing Remarks    
Location:   
VIRTUAL
Cost / RUs:                      
This is a free event for ASQ members & guests.   
0.2 RUs shall be awarded  
Registration:       
Please be sure to register for this event if you plan to attend.
 

Location

Online Instructions:
Url: http://asq.webex.com/weblink/register/r3e1c827f7afb998aae86a95d22699873
Login: Please be sure to register for this event if you plan to attend.