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!

Exploring edX’s “Final” Tax Returns: Revenue Surges, Losses Mount, and Contributions Decline

White-Labeling in Online Education: Whose Credential Is It Anyway?

10 Best Assembly Language Courses for 2025: Bare-Metal Programming

Why Duolingo is Worth More Than Coursera and Udemy Combined

Harvard’s Intro to Python: Earn a Free Certificate

7 Best Sketch Courses for 2025

6 Best Penetration Testing Courses in 2025

Writing as Enchantment: Inside Alan Moore’s BBC Maestro Course

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

Chinese Edtech Pivots: Well-rounded Education, Hardware, Agriculture E-commerce, Fast-Food, Garments, and More

New CEO, New Structure: Greg Hart Reshapes Coursera’s Reporting

8 Best Crochet Courses for 2025: Practical, Enriching, Creative

10 Best Organic Chemistry Courses for 2025

Coursera, Udemy, and the $10M+ Video Privacy Battle: Class Action Update

20 Most Cited Research Papers on MOOCs

The Business of Online Education: A Deep Dive Into Thinkific’s Financials