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The fundamentals of medical device QMS
The fundamentals of medical device QMS
The fundamentals of medical device QMS

About the Course

Introduction to this course: 

This course explores the structure, key concepts, and requirements of medical device QMS as per ISO 13485:2016.


Who should attend: 

This course is designed for professionals involved in QA/QC, compliance officers, regulatory affairs, manufacturing, and anyone who wishes to gain an understanding of the quality management system for medical devices.


Learning Outcomes: 

By the end of this lesson, you will be able to:

Recall the structure and key components of ISO 13485:2016.


What will I gain: 

Participants will gain a thorough understanding of the structure and key concepts of ISO 13485:2016.


Prerequisites: 

Participants should have a basic understanding of quality management of medical devices.  Familiarity with ISO 9001 and other international standards is beneficial.


Additional information: 


Course duration: 00:36:51

Course code/version (effective date): L-148/v1.0 (07/09/2023)

Course Categories

Quality Management
Medical Device
Course Progress
Not started
Enroll
Course Outline
  1. The fundamentals of medical device QMS
    1. Lesson 1: Medical Device Quality Management System
    2. Lesson 2: ISO 13485:2016: Structure, Clauses, and Key Concepts (Part 1)
    3. Lesson 3: ISO 13485:2016: Key Concepts (Part 2)
    4. Lesson 4: ISO 13485:2016: Key Concepts (Part 3)
    5. Lesson 5: ISO 13485:2016: Key Concepts (Part 4)
    6. Lesson 6: ISO 13485:2016: Key Concepts (Part 5)
    7. Reading: Differences between ISO 13485 and ISO 9001: When do I need each?
  2. Additional resources
    1. Mind map: Risk Management for Medical Devices
course
The fundamentals of medical device QMS
The fundamentals of medical device QMS
Course Progress
Not started
Enroll

About the Course

Introduction to this course: 

This course explores the structure, key concepts, and requirements of medical device QMS as per ISO 13485:2016.


Who should attend: 

This course is designed for professionals involved in QA/QC, compliance officers, regulatory affairs, manufacturing, and anyone who wishes to gain an understanding of the quality management system for medical devices.


Learning Outcomes: 

By the end of this lesson, you will be able to:

Recall the structure and key components of ISO 13485:2016.


What will I gain: 

Participants will gain a thorough understanding of the structure and key concepts of ISO 13485:2016.


Prerequisites: 

Participants should have a basic understanding of quality management of medical devices.  Familiarity with ISO 9001 and other international standards is beneficial.


Additional information: 


Course duration: 00:36:51

Course code/version (effective date): L-148/v1.0 (07/09/2023)

Course Outline
  1. The fundamentals of medical device QMS
    1. Lesson 1: Medical Device Quality Management System
    2. Lesson 2: ISO 13485:2016: Structure, Clauses, and Key Concepts (Part 1)
    3. Lesson 3: ISO 13485:2016: Key Concepts (Part 2)
    4. Lesson 4: ISO 13485:2016: Key Concepts (Part 3)
    5. Lesson 5: ISO 13485:2016: Key Concepts (Part 4)
    6. Lesson 6: ISO 13485:2016: Key Concepts (Part 5)
    7. Reading: Differences between ISO 13485 and ISO 9001: When do I need each?
  2. Additional resources
    1. Mind map: Risk Management for Medical Devices

Course Categories

Quality Management
Medical Device
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