ISO 13485 Medical Devices Quality Management System – Training Courses
$399.00
As an international standard, 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.
However, ISO 13485 can also be operated by other parties such as certification bodies which can assist in the certification processes. ISO 13485 serves as a tool for organizations to develop and retain their processes efficiently. Organizations that are striving for continuous improvement will benefit from this standard by being able to provide safe and competent medical devices and achieve the trust of customers.
Description
ISO 13485Â 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.
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
Course Agenda
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
General Information
- Certification and examination fees are included in the price of the training course.
- PECB will provide over 450 pages of instructional materials containing explanations, guidance, and practical examples.
- An attendance record worth 31 CPD (Continuing Professional Development) credits will be issued to participants who have attended the training course.
- In case of exam failure, the candidate can retake the exam once for free within 12 months following the initial exam date.
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