Angela Jones Sterilization Bottleneck for a Large OEM A large, multi‑billion‑dollar medical device manufacturer was producing high‑volume components for global markets under EU MDR, and FDA‑regulated conditions. The company relied heavily on third‑party ... MedTechOperations MedicalDevices RegulatoryCompliance Sterilization SupplyChainStrategy Jan 28, 2026
Advasaf LLC, Kashyap Malkan Selecting the Right Contract Manufacturing Model for Medical Devices Introduction As medical device portfolios become more complex and regulatory scrutiny continues to intensify, many OEMs are re-evaluating how manufacturing, sterilization, and packaging fit into their... ISO13485 MedTechOperations MedicalDevices RegulatoryCompliance Sterilization SupplyChainStrategy Jan 8, 2026
Advasaf LLC, Kashyap Malkan Lets not forget STEAM is really HOT water… Water is a universal solvent that has numerous applications. It is also the safest for use in all applications. Our application for sterilization in a giant autoclave to kill bioburden has opened equa... ISO13485 ISO17665 MedicalDevices Moistheat advasaf autoclave pharmaceutical steamsterilization Aug 23, 2023
