Market Validation for Complex Medical Devices
Webinar Date: June 11th, 2025
Webinar Date: July 25th, 2024
Speaker: Aaron Joseph, Principal Consultant, Sunstone Pilot, Inc.
Details: 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.
Aaron discusses the challenges of managing post-market changes to medical devices, the shortcomings of traditional quality system approaches, what is meant by "re-entrant design controls," and more!
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