Alison's New App is now available on iOS and Android! Download Now

ISO 13485:2016 - Quality Management Systems for Medical Devices
Beginner Level

ISO 13485:2016 - Quality Management Systems for Medical Devices

40,297Learners already enrolled
274
Not Interested
  • 1.5-3 Avg Hours
  • CPD Accredited
Start Course Now

ISO 13485:2016 - Quality Management Systems for Medical Devices

In this free online course learn about the requirements of Quality Management Systems for Medical Device organizations and its regulatory aspects.
This free online ISO 13485 certification training course will teach you about quality management systems for medical devices. You will study the ISO 13485:2016 standard, learn how it was developed, and look i... This free online ISO 13485 certification training course will teach you about quality management systems for medical devices. You will study the ISO 13485:2016 standard, learn how it was developed, and look into the practical steps to company certification on ISO 13485. You will cover the types of available personal certifications and look closely at standard terminologies related to stakeholders, product, QMS, Risk and Sterilization, and more!
COURSE PUBLISHER SM Waqas ImamLean Six Sigma professional, Trainer

What You Will Learn In This Free Course

  • Compare the revision of ISO 13485:2...
  • List the main clauses of the ISO 13...
  • Define important terminologies abou...
  • Explain the purpose of other intern...
  • Compare the revision of ISO 13485:2003 to ISO 13485:2016
  • List the main clauses of the ISO 13485:2016 standard along with the requirements
  • Define important terminologies about medical devices as per ISO 13485:2016
  • Explain the purpose of other international and regulatory standards like ISO 14971 and FDA 21 CFR Part 820
  • Compare ISO 13485 with FDA 21 CFR Part 820
  • Describe how to manage the requirements about medical device files
  • Illustrate how to assimilate work environment and contamination control requirements
  • Describe how to manage the requirements about design and development
View All Learning Outcomes View Less
Course Modules
Course Description
Alison Certificates

Explore Careers Related To This Course

Quality Assurance Specialist Quality Assurance Specialist
Every time we use a product/service that brings us immense satisfaction, we owe it to a dedicated Quality Assurance Specialist who strives to be incredibly thorough in ensuring the manufacturing proce

  • Average Salary Flag$69,574
  • Traits realistic
Learn More
Postal Inspector Postal Inspector
In recent years, Postal Inspectors have played an increasingly critical role in ensuring that nefarious individuals do not misuse the postal service to conduct fraud and mail-related crimes.

  • Average Salary Flag$146,643
  • Traits realistic investigative
Learn More

Complete This CPD Accredited Course & Get Your certificate!

  • Certify Your Skills
    A CPD accredited Alison Diploma/Certificate certifies the skills you’ve learned
  • Stand Out From The Crowd
    Add your Alison Certification to your resumé and stay ahead of the competition
  • Advance in Your Career
    Share your Alison Certification with potential employers to show off your skills and capabilities

Learner Reviews & Feedback For ISO 13485:2016 - Quality Management Systems for Medical Devices

274
Gregory F. Alison Graduate
loved this course
This course was every educational, learned a lot from this course, I'll continue reading more about ISO. It's never to late to keep on learning.
Was This Review Helpful?
Report
Rajkumar S. Alison Graduate
loved this course
Good for me
Was This Review Helpful?
Report
Ahmed K. Alison Graduate
loved this course
it was an amazing & extensive course covering all the major essentials regarding iso 13485:2016.
Was This Review Helpful?
Report
Eberechi N. Alison Graduate
loved this course
great course
Was This Review Helpful?
Report
Ade Rezki I. Alison Graduate
loved this course
Good course
Was This Review Helpful?
Report
View 42 More Reviews
Back to course information

Want to create a customised learning path for your team?

Our dedicated Learning Advisors are here to help you curate a customised learning path tailored to your organisation's needs and goals.

Activate your Free LMS now Speak to Learning Advisor

Not sure where to begin? Or even what you want to do?

Discover the career most suitable for you and get started in the field with a step-by-step plan.

Get your Plan

About Your Alison Course Publisher

SM Waqas Imam's Alison Stats

SM Waqas Imam's Alison Stats

946,314 Learners27 Courses9,707 Learners Benefited From Their Courses

Frequently Asked Questions

What is the ISO 13485 quality management system (QMS)?
What is a medical device quality management system?
What is the difference between the ISO 9001 and ISO 13485 systems?
Which is the best quality management systems for medical devices course?