Optimizing CAPAs in the Medical Device Industry
This white paper explores how to best utilize CAPAs in the medical device industry including best practices, common pitfalls, and how to avoid “death by CAPA”.
Regulatory Affairs
Learn more about our Regulatory Affairs work.
Third-Party Servicing of Medical Devices
Proper servicing of complex, life-saving medical devices is vital to their safe and effective functioning and the safety of patients and device users.
The Virtual The MedTech Conference Opens with On-Demand Offerings
WASHINGTON, D.C. – The Virtual The MedTech Conference, powered by AdvaMed®, kicks off its first week of on-demand content with a slate of informative sessions providing something for everyone in…
FDA Warns of “Tipping Point” with Medical Device Supplies and EtO Facility Closures
WASHINGTON, DC. – A top FDA official warned that additional closures of ethylene oxide (EtO) sterilization plants could lead to shortages of critical medical devices across the country.
AdvaMed®: Neonatal Products Provided to 80 Percent of U.S. Hospitals Threatened by Potential Medline Shutdown
Medela LLC, headquartered in McHenry, Illinois, today wrote to Illinois state house speaker Michael Madigan saying they “respectfully oppose HB 3888 and HB 3885 because their restriction to EO use would…
AdvaMed® Comments on FDA Statement on Potential Device Shortages
WASHINGTON, D.C. – AdvaMed® released a statement on FDA’s announcement today that the agency is concerned about medical device shortages in light of two recent closures of ethylene oxide sterilization…
Nation’s Premier Surgeons Stress Importance of Ethylene Oxide for Medical Device Sterilization
WASHINGTON, D.C. – This week, six leading medical groups sent a letter to FDA urging caution as regulators consider limiting the use of ethylene oxide (EtO) for medical device sterilization. The surgeons…