ISO 13485 Foundation
Why should you attend?
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
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
Educational approach
- Lecture sessions are illustrated with practical questions and examples
- Practical exercises include examples and discussions
- Practice tests are similar to the Certificate Exam
Prerequisites
None
More Details
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Day 1: Introduction to Medical Devices Quality Management System (MDQMS) concepts as required by ISO 13485
Day 2: Medical Devices Quality Management System requirements and Certificate Exam
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The exam fully meets the requirements of the PECB Examination and Certificate Programme. It covers the following competency domains:
Domain 1: Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS)
Domain 2: Medical Devices Quality Management System (MDQMS)
For specific information about exam type, languages available, and other details, please visit the List of PECB Exams and the Examination Rules and Policies.
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After successfully completing the exam, you can apply for the credential shown on the table below.
The certificate requirements for the ISO 13485 Foundation are:
Designation Exam Professional experience MS audit/assessment experience MDQMMS project experience Other requirements PECB Certificate Holder in ISO 13485 Foundation Pass the PECB ISO 13485 Foundation Exam None None None Signing the PECB Code of Ethics
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- Certificate and examination fees are included in the price of the training course
- 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.
- In case of exam failure, you can retake the exam within 12 months for free
