Title: Module 8 Overview: ISO 13485
Course: PW-Course-Import-Test > Section: Module 8: ISO 13485

Module 8

In this module we will explore ISO 13485 and it’s relevance to a large number of American medical device manufacturers that market medical devices in the USA and Canada, Europe and other countries that recognize this standard (i.e. equivalent to 21 CFR 820).

21 CFR 820 is a regulation in the USA. Other countries have their own regulatory requirements and some countries recognize ISO 13485. Firms that do business internationally frequently have a “harmonized” quality system that captures the requirements of both 21 CFR 820 and ISO 13485, therefore producing products that can be sold in both markets.

Watch

Watch "ISO 13485: Foundation and Basic Principles." It provides a high level video overview of ISO 13485.

ISO 13485: Foundation and Basic Principles

21 CFR and ISO 13485 are similar but not the same. In this section we will compare the QSR with ISO 13485.

Competency

After completing this module, you will be able to distinguish the key differences between the requirements of 21 CFR820 vs. ISO 13485.

Learning Objectives

- Recognize the interdependency between the 21 CFR 820, ISO 13485 and the subordinate regulations
- Summarize the key differences between ISO standard and 21 CFR 820 e.g. which sections are different
- Analyze the consequences of non-compliance to both 21 CFR 820 and ISO 13485

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