ISO 13485 Foundation Training
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.
Benefits of ISO 13485
By becoming an ISO 13485 certified professional, you will be able to:
- Increase the number of job opportunities
- Create new business connections
- Gain competitive advantage
- Increase effectiveness and lower costs
- Offer expertise on improving work processes
- Offer safer and more efficient medical devices
- Increase customer satisfaction
How do I get started with ISO 13485 Training?
If you are willing to take the challenge of obtaining an ISO 13485 certification, our experts will ensure a qualitative experience where your needs will be met, and you will become part of our global network.
ISO 13485 Foundation
Why should you attend?
- 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 apply for the “PECB Certified ISO 13485 Foundation” credential. A PECB Foundation Certificate shows that you have understood the fundamental methodologies, requirements, framework and management approach.
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 Certification Exam
Prerequisites
None
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- Week End Classes For Professionals SAT | SUN
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- Online Classes – Live Virtual Class (L.V.C), Online Training
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