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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

Medical Device
Quality Management
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
  3. Survey
    1. Course survey
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
  3. Survey
    1. Course survey

Course Categories

Medical Device
Quality Management
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