Voler Systems Presents:
"Embracing Change: Managing Medical Devices That Are Never Finished"


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Thursday, July 25, 2024
12:00 - 1:00 PM Pacific Time

Online Webinar


Aaron Joseph Headshot

How do we manage upgrades to a new medical device after product launch? If you don’t expect to ever make changes to the product then this may not be a concern at all. However, if you’re developing software-intensive, connected devices or capital equipment, then this IS a big concern!

These types of medical devices need to be upgraded throughout their lifetimes. Therefore, the majority of development projects will likely be product upgrades, not new product development - and your quality system should be designed with this in mind.

Topics to be covered:

The challenges of managing post-market changes to medical devices, and...
  • The shortcomings of traditional quality system approaches
  • An explanation of what is meant by "re-entrant design controls"
  • How to modify quality systems to systematically and efficiently support product upgrades                       (including software patches and cybersecurity patches)
  • Q&A session about maintaining compliance throughout planned & unplanned product changes


  • Aaron Joseph, Principal Consultant - Sunstone Pilot, Inc.

Aaron Joseph is a biomedical engineer and Principal Consultant at Sunstone Pilot, Inc. where he helps medical device companies implement modern processes for development of complex, software-intensive medical devices.

Aaron has over 20 years of experience in medical device development over a wide range of products, including surgical robotics systems, wearables, x-ray imaging system, and catheters.

He is an avid promoter of lean and agile methods for medical device development, and is always looking for new ways to make it faster and cheaper to bring new medical devices to market.

Aaron has a BS in Electrical Engineering from Rice University, and an MS in Bioengineering from the University of Washington.

Please join Voler Systems for this insightful session on July 25, 2024.