The conformity of Medical Devices and In-vitro Diagnostic Medical Device
according to each regional regulatory in the world such as, EEC-decrees
93/42/EEC, 90/385/EEC and 98/79/EEC for Europe, US FDA for United States of
America, CMDCAS for Canada, must be assessed before sale is permitted.
The preferred method to prove the conformity is the certification of the
Quality Management System according ISO 9001 and/or ISO 13485, ISO 13488
by a Conformity Assessment Body (CAB) or notified body.
The result of a positive assessment is the authorization for each regional
approved-identification such as the CE-mark and the permission to sell the
high quality medical device.
This interactive course provides the basic knowledge and understanding of
the key requirements and significant changes to the new ISO 13485:2003
Medical devices Quality management Systems — Requirements for regulatory
This is an introductory class to the medical device requirements of the ISO
13485:2003 Quality Management System for the organization. Here are the
learning objectives for the two days training program; after completing this
program, participants will be able to:
Have a basic awareness about medical devices management
systems based on ISO 13485: 2003 Standard and its benefits.
Understand basic requirements of and the mechanism of ISO
Quality Managers, RA Managers, Auditors of Medical Device, Executives &
Senior Management, Cross functional team members of implementation
project, Suppliers to the organization.
Duration: 1 day
b. The background of ISO 13485:2003.
c. GHTF Overview
d. The overview of Regulatory Requirements on medical devices.
- Medical Device QMS Standard
a. Key Issues in Medical Devices QMS.
b. Guidance Standards.
c. Roles and Responsibilities.
d. Medical devices classifications.
- ISO 13485 Requirements Overview
a. Scope of Applications.
b. Documentation requirements.
c. Management Responsibilities.
d. Resources Management.
e. Product Realization.
f. Measurement, Analyze and Improvement.