![ISO 13485 Management System For Medical Devices (MDQMS)](https://cdga-training.com/uploads/courses/8888.jpg)
By the end of this course, delegates will be able to:
Managers, Team Leaders, Line Managers, Superintendents, OE Champions, Quality and Project Managers, Supervisors, Executives, Internal and External Auditors, Members of IT Team, Health & Safety Managers, Risk Managers, Business Process Owners, Business Finance Managers, Business Risk Managers, Regulatory Compliance Managers, Project Managers, Continuity, Risk, Quality, IT and Environmental Managers, Anyone involved in the system development, implementation and maintenance, Regulatory Affairs Managers, Consultants, Anyone who is involved in
ISO standards, Anyone involved in defining, planning, or implementing an ISO 13485 based quality management system, Anyone involved in the medical field, Professionals from the medical device industry wanting to gain a comprehensive knowledge of the main processes of MDQMS, Staff involved in the implementation of the ISO 13485 standard, Expert advisors in quality management for the medical device industry, Managers responsible for implementing MDQMS
The ISO 13485 standard is an effective solution to meet the comprehensive requirements for a QMS. Adopting ISO 13485 provides a practical foundation for manufacturers to address the Medical Device Directives, regulations and responsibilities as well as demonstrating a commitment to the safety and quality of medical devices. ISO 13485 is a stand-alone QMS standard, derived from the internationally recognized and accepted ISO 9000 quality management standard series. ISO 13485 adapts the ISO 9000 process-based model for a regulated medical device manufacturing environment. While ISO 13485 is based on the ISO 9001 process model concepts of Plan, Do, Check, Act, it is designed for regulatory compliance. It is more prescriptive in nature and requires a more thoroughly documented quality management system. This course enables participants to learn about the best practices for implementing and managing medical devices quality management system (MDQMS) as specified in ISO 13485:2016. The participant will learn the different components of a MDQMS such as quality manual, required procedures, records, measuring performance, management commitment, internal audit, management review and maintaining effectiveness. You will be able to:
CDGA attendance certificate will be issued to all attendees completing minimum of 80% of the total course duration.
Code | Date | Venue | Fees | Register |
---|---|---|---|---|
ISO121-03 | 13-10-2024 | Jeddah | USD 5450 | |
ISO121-04 | 08-12-2024 | Dubai | USD 5450 |
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