5 Differences Between ISO 13485 & FDAs Medical Device QSR | | Patient Guard 

Welcome to Patient Guard! In this video, we dive into the critical distinctions between ISO 13485 for global markets and the FDA's Medical Device Quality System Regulation (QSR) CFR 21 Part 820. Whilst the FDA is in the process of updating CFR 21 Part 820 to align more closely with ISO 13485, two standards currently have some distinct differences and understanding these differences is vital for maintaining compliance and ensuring the safety and efficacy of medical devices. For more on this specific blog post, please Click Here: patientguard.c...
Visit our official website:
🌐 patientguard.com
If you are looking for Quality Assurance Templates to help you with your Quality Management System, head over to: qmsregs.com
🔔 Don't forget to like, subscribe, and hit the notification bell to stay updated with our latest videos.
#PatientGuard #ISO13485 #FDAQSR #QSR #QualityManagementSystem #MedicalDeviceCompliance #MedicalDeviceRegulation #MedicalDevices #QualityAssurance #HealthcareCompliance #MedTech #DifferencesBetweenISO13485andQSR