Learning Outcomes

Quality Management System of Medical Devices' Suppliers and Manufacturers

ISO 13485:2016 Important Terminologies

Publication of ISO 13485:2016 and Context of Publication

Lesson Summary

This module explains the existing relevant standards and regulation for medical devices' industry and enlightens the revision of ISO 13485. It also presents some important terminologies with related definitions as defined by ISO 13485; which are arranged in separate groups. It also covers the comparison of ISO 13485 to FDA 21 CFR Part 820. All mandatory documents required by different clauses of the ISO 13485:2016 standard are also enumerated in this module along with its given clause reference.

Quality Management System Requirements

Management Responsibility and Resource Management

Product Realization – Planning to Design and Development

Product Realization – Purchasing and Production

In this module you will learn the operations of the QMS for a medical devices company. It covers top management requirements and offers ideas to manage resource requirements in the organization. It enlightens the concept of medical devices' product realization. It covers all elements of product realization such as quality planning, customer related processes, design and development, purchasing and production etc.

Monitoring and Measurement

Control of Non-Conforming Product

Analysis and Improvement

In this module, Clause - 8 of the ISO 13485:2016 standard is taught. Clause - 8 specifies the general requirements, management of monitoring and measurement issues, nonconforming product management, data analysis etc. Within this clause - 8, Clause - 8.5 is on improvement which paves out ways for the organization to improve its system, products, and processes through the framework of corrective and preventive actions.

ISO 13485:2016 - Quality Management Systems for Medical Devices - Assessment

In this free online course learn about the requirements of Quality Management Systems for Medical Device organizations and its regulatory aspects.

ISO 13485:2016 - Quality Management Systems for Medical Devices

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!

The Rise of AI Search: ChatGPT Surpasses DuckDuckGo, Threatens Bing

From Zero to Cybersecurity Analyst: How Google’s Certificate Can Launch Your Career

10 Best Organic Chemistry Courses for 2025

[2025] Massive List of Thousands of Free Certificates and Badges

6 Best Courses to Become an Influencer in 2025

Udemy Announces Layoffs Without Saying ‘Layoffs’

10 Best Programming Courses for 2025

5 Best Free Raspberry Pi Courses for Beginners in 2025

[2025] 470+ Hours of Free LinkedIn Learning Courses with Free Certification

How GenAI Costs Sank Duolingo’s Stock 20% (A Non-AI Generated Analysis)

Coursera Bets $100 Million That Andrew Ng Can Do What Coursera Can’t

Udacity’s 2021: Year in Review

7 Best Technical Writing Courses to Master Documentation and Communication

2U Lays Off Staff for the Sixth Time Since its $800M edX Acquisition

Coursera Q4 2025: 197M Learners, ~$197M Revenue, ~$27M in Losses

Coursera 10-K Highlights: Lower Partner Revenue Share, 1k+ Employees