ISO 13485 Quality Management Foundation
ISO 13485 determines the requirements for the medical devices industry. This standard was established to be used by companies during the life cycle of medical devices, from the production to post-production, including decommission and disposal.
Description
ISO 13485 Foundation training enables you to learn the basic elements to implement and manage a Medical Devices Quality Management System (MDQMS) as specified in ISO 13485. During this training course, you will be able to understand the different modules of a MDQMS, including MDQMS policy, procedures, performance measurements, management commitment, internal audit, management review and continual improvement.
After completing this course, you can sit for the exam and gain "Certified ISO 13485 Foundation” Certification. This Certificate shows that you have understood the fundamental methodologies, requirements, framework and management approach.
About This Course
Learning Objectives
- Understand the elements and operations of a Medical Devices Quality Management System (MDQMS)
- Acknowledge the correlation between ISO 13485 and other standards and regulatory frameworks
- Understand the approaches, methods and techniques used for the implementation and management of a MDQMS
Course Agenda
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Day 1: Introduction to Medical Devices Quality Management System (MDQMS) concepts as required by ISO 13485
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Day 2: Medical Devices Quality Management System requirements and Certification Exam
Assessment
Delegates sit a combined exam, consisting of in-course quizzes and exercises, as well as a final 40 question, multiple choice exam on Day 2 of the course. The overall passing score is 70%, to be achieved within the 60 minute time allowance.
Exam results are provided within 24 hours, with both a Certificate and a digital badge provided as proof of success.
Prerequisites
None
What's Included?
- Certification fees are included on the exam price
- Training material containing over 200 pages of information and practical examples will be distributed
- An attestation of course completion worth 14 CPD (Continuing Professional Development) credits will be issued to the participants who have attended the training course.
Who Should Attend?
- Individuals involved in Medical Devices Quality Management
- Individuals seeking to gain knowledge about the main processes of Medical Devices Quality Management Systems (MDQMS)
- Individuals interested to pursue a career in Medical Devices Quality Management
Accreditation
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