Medical Device & IVD Regulatory | SCIENCE ARENA

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Quality Management System

Medical Device and IVD Manufacturing: Compressed Air Quality, Applications and Compliance Considerations

bySCIENCE ARENA -October 26, 2026

Compressed air is widely used throughout medical device and In Vitro Diagnostic (IVD) manu…

Regulatory Research

PFAS in Medical Devices: Material Applications, Regulatory Challenges, and Future Alternatives

bySCIENCE ARENA -September 27, 2026

Per- and polyfluoroalkyl substances (PFAS), often referred to as “forever chemicals,” are a larg…

Regulatory Research

Device History Records (DHR) and Batch Production Records (BPR): Understanding Yield, Overage, Scrap, and Rughage Calculations in Medical Device Manufacturing

bySCIENCE ARENA -August 20, 2026

Medical device manufacturers are required to maintain documented evidence demonstrating that dev…

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