Unomedical, which supplies diabetes tech firms including Medtronic, Tandem Diabetes Care and Beta Bionics, received more than 5,000 complaints about leaking infusion sets between 2023 and 2025.

The Food and Drug Administration warning letter detailed unreported low blood sugar and a software change to correct for delayed glucose readings.

After a quiet January marked by administrative transition and internal upheaval at FDA, enforcement activity has accelerated sharply in 2025. No warning letters were issued in the first month of the ...

DUBLIN--(BUSINESS WIRE)--The "Medical Devices: Developing Effective Post Market Surveillance and Complaint Handling Systems" training has been added to ...

DUBLIN--(BUSINESS WIRE)--The "Medical Devices: Developing Effective Post Market Surveillance and Complaint Handling Systems Course" training has been added to ResearchAndMarkets.com's offering. This ...

Is your medical device company ready for the QMSR shift? Engineer Aldo Vidinha explains why "checkbox compliance" is over and how the FDA’s alignment with ISO 13485 redefines quality as a connected, ...

On Monday, February 2, a new final rule from FDA changing QMS requirements for medical devices went into effect. Manufacturers have had over two years to comply with the new rule, which is now full ...

The "Medical Devices: Developing Effective Post Market Surveillance and Complaint Handling Systems Course (Jan 22nd - Jan 23rd, 2026)" training has been added to ...