Title: What are the Regulatory and Business Impacts of ISO Certification Audits vs. FDA Investigations?
Course: PW-Course-Import-Test > Section: Module 8: ISO 13485

Module 8

Conformity to ISO 13485 is required in order to apply for a CE Mark. Medical devices that are sold in countries that require a CE Mark must apply for and receive CE Mark approval before the device can be commercially sold in applicable countries. Failure to maintain conformity could result in the loss of the CE Mark, which would effectively exclude a medical device firm from further sales in that Country.

We discussed in module one the potential consequences of non-compliance to 21 CFR 820. Non compliance to ISO also has significant non-compliance penalties, but most are associated with the potential loss of the CE Mark. This is an international business penalty - not an FDA penalty.

Watch

Watch "Introduction to CE Marking", a rather long (45 minutes) video, but it provides a very comprehensive explanation of CE Marking requirements.

Introduction to CE Marking