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| Course Fee | 1,050 |
|
Total Fees (with exam) |
1,050 (USD) |
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Koenig Learning Stack
Free Pre-requisite TrainingJoin a free session to assess your readiness for the course. This session will help you understand the course structure and evaluate your current knowledge level to start with confidence.
Assessments (Qubits)Take assessments to measure your progress clearly. Koenig's Qubits assessments identify your strengths and areas for improvement, helping you focus effectively on your learning goals.
Post Training ReportsReceive comprehensive post-training reports summarizing your performance. These reports offer clear feedback and recommendations to help you confidently take the next steps in your learning journey.
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Free Lab ExtensionsExtend your lab time at no extra cost. With free lab extensions, you get additional practice to sharpen your skills, ensuring thorough understanding and mastery of practical tasks.
Free Revision Classes Join our free revision classes to reinforce your learning. These classes revisit important topics, clarify doubts, and help solidify your understanding for better training outcomes.
Inclusions in Koenig's Learning Stack may vary as per policies of OEMs
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♱ Excluding VAT/GST
You can request classroom training in any city on any date by Requesting More Information
Inclusions in Koenig's Learning Stack may vary as per policies of OEMs
To successfully undertake training in the ISO 13485 Foundation course, it is beneficial for participants to have the following minimum prerequisites:
These prerequisites ensure that participants can effectively engage with the course material and contribute to discussions. However, the course is designed to provide foundational knowledge, so a willingness to learn and engage with the content is the most critical requirement.
| 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.
