Angela Jones Empowering Innovation: How Strategic Guidance Helped Build Advasaf Launching and scaling a regulated medical manufacturing business is not a simple journey. It requires navigating FDA requirements, quality systems, cybersecurity controls, capital planning, and long-t... #Advasaf #contractsterilization #medicaldevices MedTechOperations Universities of Wisconsin SBDC Mar 12, 2026
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