Jun 14, 2022

FDA QSR vs. QMSR: What Medical Device Manufacturers That DO NOT Have ISO 13485 Certification Need to Know

Aug 23, 2021

Will Your Team Be Ready for a (Live and In-Person) FDA Medical Device Inspection?

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When Will FDA Resume Medical Device Inspections?

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Non-Product Software Risk Assessment for Medical Device Manufacturers

fda-21-cfr-part-11

Apr 23, 2021

FDA 21 CFR Part 11 Compliance: Are You Complying With These Four Critical Requirements?