Learn how to meet the FDA’s requirements for selling medical devices in the USA on this Quality System Regulations for Medical Devices training course.
This practical 1-day course examines the demands of the FDA’s Quality System Regulations (QSR) and related product safety requirements with a view to the design and delivery of compliant products.
Interactive workshops and discussions will allow your team to consider together how they may successfully implement methods and ideas learned on this course.
Click to open the QSR for Medical Devices course flyer.
This course will be helpful to anyone involved in the development and sales of medical devices to markets where the FDA’s Quality Systems Regulations are applied. This includes:
- executives and senior management
- R&D managers/engineers and members of design review teams
- RA/QA managers and management representatives
- members of multi-discipline design teams
- sales and marketing, production, shipping, MIS, purchasing
Key topics covered on this course includes:
- FDA requirements and how they might affect an organisation
- implementing the requirements effectively so as not to affect other regulatory requirements
- locating key pieces of information within the appropriate documents (DHF, DMR and DHR)
- review of related standards such as risk analysis and the applicable guidance documents
- the relationship between QSR and the Medical Devices Regulation/In Vitro Diagnostic Medical Regulation (MDR/IVDR) and ISO13485/ISO9001 standards requirements
- regulatory requirements for reporting incident/near incidents (MDR)
- addressing 21 CFR Part 11 Electronic Signature and Records
- adding value to an organisation’s management system
- preparing for an FDA Quality System Inspection Technique (QSIT) type audit
- sources of information and further development
Attendees can expect a course structure similar to the following:
- WELCOME AND INTRODUCTION
- Module 1 Overview of Medical Device Regulation in the EU
- Module 2 The USA’s FDA Approach
- Module 3 Workshop 1: The Company Design Processes
- Module 4 Comparisons – FDA/ISO/MDD
- Module 5 The Requirements of QSR
- Module 6 FDA Inspections and QSIT Audits
- Module 7 QSR Design Controls
- Module 8 Workshop 2: Using QSIT
- Module 9 Device Classification
- Module 10 Pre-Market: PMA and PMN 510 (k)
- CLOSE
By the end of this Quality System Regulations for Medical Devices training course, delegates will be able to:
- interpret the requirements of QSR and its relationship with MDR/IVDR and ISO 13485/ISO 9001 requirements
- identify the methods for successful implementation of the regulations
- prepare for an FDA QSIT-type audit and add value to an organisation’s management system
Delegates will also be awarded with a certificate of completion in recognition of their new knowledge and skills in QSR for medical devices.
