QMS Training for Medical Devices:
FDA QSR and ISO 13485:2016

Objectives

At the end of this course, participants will be able to:

• Describe the objectives of ISO 13485:2016 and FDA's QSR
• Identify the requirements of ISO 13485:2016 and FDA's QSR
• Apply the requirements of ISO 13485:2016 and FDA's QSR
• Identify the common elements found in global QMS requirements
• Describe how to plan and prepare for FDA, Notified Body, and MDSAP inspections/audits
• Identify opportunities beyond compliance, including FDA’s Case for Quality

Topics

• FDA QSR background and subpart review compared against ISO 13485 standard clauses
• Major subsystems: management controls, design controls, production and process controls, and CAPA
• Application of risk-based approach
• Going beyond the minimum requirements, including FDA's Case for Quality

Who Should Attend

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. 

Related Courses

• SOP Writing and Process Mapping for Medical Device Regulations (ISO 13485, MDSAP and EU MDR 2017/745)
• Medical Device Single Audit Program (MDSAP) Training: Preparing for a Successful Transition
• ISO 13485 Lead Auditor Training