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Oriel STAT A MATRIX is known for our in-person workshops and hands-on activities, and we use an extensive toolbox to foster similar engagement and attention in our virtual classes. The virtual version of this class is delivered as five consecutive half-day sessions.ĭaily sessions run from 1:00-5:00 p.m.
#Iso 13485 vs 21 cfr 820 how to
This course is appropriate for anyone who needs to understand how to meet the requirements of a global medical device quality system, including R&D or engineering managers management representatives product, project, and program managers RA/QA managers/engineers internal auditors compliance and legal and other cross-functional team members.
#Iso 13485 vs 21 cfr 820 iso
Identify the common elements found in global QMS requirementsĭescribe how to plan and prepare for FDA, Notified Body, and MDSAP inspections/auditsįDA QSR background and subpart review compared against ISO 13485 standard clauses Identify the requirements of ISO 13485:2016 and FDA's QSRĪpply the requirements of ISO 13485:2016 and FDA's QSR LocationĪt the end of this course, participants will be able to:ĭescribe the objectives of ISO 13485:2016 and FDA's QSR In-person classes run as full-day sessions. Virtual seminars run as 1/2-day sessions. You’ll come to understand how QSR and ISO 13485:2016 align with one another, how they can be harmonized to maximize efficiency, and where there are opportunities to go beyond the minimum requirements to optimize performance.ĭesigned for those who are new to the medical device field as well as experienced practitioners looking to refresh their knowledge, this course will provide you with a solid foundation on which to build a successful career in medical device RA/QA. You will address the major QMS subsystems and learn how to prepare for a Notified Body or FDA inspection. Through engaging classroom discussions, workshops, and activities, you will follow a product’s life cycle to explore how different elements of ISO 13485 and FDA’s QSR should be implemented at each life-cycle phase. The must-take foundation course for all medical device RA/QA professionals!Īt the end of this medical device QMS training course, you’ll understand the basic requirements for FDA’s Quality System Regulation (QSR), ISO 13485:2016, and more. Can't travel? This class is also available virtually.