BS EN ISO 13485:2016+A11:2021 Requirements

This ON DEMAND 16-hour e-course teaches a detailed understanding of the concepts and requirements of the ISO 13485 Medical Device Quality Management standard and includes a certified training Certificate of Competence. 1.6 CEUs.

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Course curriculum

1. How to use this course
1. ISO 13485-Lesson-02
2. ISO 13485-Lesson-01 and 02-QUIZ
1. ISO 13485-Lesson-03
2. ISO 13485-Lesson-03-QUIZ
1. ISO 13485-Lesson-04a
2. ISO 13485-Lesson-04a-QUIZ
3. ISO 13485-Lesson-04b
4. ISO 13485-Lesson-04b_QUIZ
1. Video-Summary-Leadership requirements
2. ISO 13485-Lesson-05
3. ISO 13485-Lesson-05-QUIZ
1. Video-Summary-Support requirements
2. ISO 13485-Lesson-06
3. ISO 13485-Lesson-06-QUIZ
1. Video-Summary-Planning requirements
2. ISO 13485-Lesson-07a
3. ISO 13485-Lesson-07a-QUIZ
4. ISO 13485-Lesson-07b
5. ISO 13485-Lesson-07b-QUIZ
6. ISO 13485-Lesson-07c
7. ISO 13485-Lesson-07c-QUIZ
8. ISO 13485-Lesson-07d
9. ISO 13485-Lesson-07d-QUIZ
10. ISO 13485-Lesson-07e
11. ISO 13485-Lesson-07e-QUIZ
1. ISO 13485-Lesson-08a
2. ISO 13485-Lesson-08a-QUIZ
3. ISO 13485-Lesson-08b
4. ISO 13485-Lesson-08b-QUIZ
1. ISO 13485-Lesson-09-Annex
1. Student Handouts
1. Congratulations

About this course

$300.00
33 lessons
0 hours of video content

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Velocity 360 USA Training | UK

BS EN ISO 13485:2016+A11:2021 Requirements

Course curriculum

Welcome to the course!

Overview | Clarification of Concepts | The Process Approach

Key Terms and definitions

Quality Management System

Management Responsibility

Resource Management

Product Realization

Measurement, Analysis and Improvement

ISO 13485 - Annex

Student Handouts

Next Steps

About this course

Discover your potential, starting today