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We're here to help you find itThe ISO 13485 Foundation course is designed to introduce learners to the key concepts and requirements of the ISO 13485:2016 standard, which pertains to the Quality Management Systems (QMS) for medical devices. This course equips participants with the baseline knowledge necessary to understand and implement the standards within an organization, ensuring that medical devices meet both customer and regulatory demands.
Module 1 provides an overview of the ISO 13485:2016 standard and underscores its significance for organizations in the medical device industry, while Module 2 delves into the specific QMS requirements, including general and documentation needs, Management responsibility, Allocation of resources, Product realization, Infrastructure, and risk management.
By the end of the course, those who complete the ISO 13485 training will be well-prepared to contribute to their organization's objectives and may have the opportunity to take a certification exam to earn their ISO 13485 certification. This foundation is crucial for professionals aiming to ensure quality and compliance in the highly regulated medical device sector.
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USD
View Fees Breakdown
| Course Fee | 1,050 |
|
Total Fees (with exam) |
1,050 (USD) |
♱ Excluding VAT/GST
You can request classroom training in any city on any date by Requesting More Information
♱ Excluding VAT/GST
You can request classroom training in any city on any date by Requesting More Information
| Exam Component | Details |
|---|---|
| Exam Name | ISO 13485 Foundation Certification Exam |
| Exam Type | Multiple Choice Questions (MCQs) |
| Total Questions | Typically 40-60 questions (may vary by provider) |
| Passing Score | Generally around 60-70% (varies by provider) |
| Exam Duration | Approximately 60-90 minutes depending on the provider |
| Language | English (other languages might be available depending on the provider) |
| Exam Provider | Various certification bodies |
| Exam Registration | Through the certification body's official website or authorized centers |
| Certification Validity | Usually doesn't expire, but organizations may recommend updates |
| Recommended Training | ISO 13485 Foundation Training Course by the certification provider |
The ISO 13485 Foundation course imparts crucial knowledge on MDQMS for professionals in the medical device sector.
Gain foundational insights into the ISO 13485:2016 standard, comprehend its significance for quality management in the medical device industry, and learn the key requirements for certification.
