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?
Aug 16, 2021
When Will FDA Resume Medical Device Inspections?
May 03, 2021
Non-Product Software Risk Assessment for Medical Device Manufacturers
Apr 23, 2021
FDA 21 CFR Part 11 Compliance: Are You Complying With These Four Critical Requirements?