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ISO 13485 Standard

Understanding the Requirements

ISO 13485 is a reference standard for quality management systems in the medical devices sector.

Why become ISO 13485 certified?

Compliance with ISO 13485 enables implementation of a management system based on the process approach, risk management and medical device safety requirements.
Certification demonstrates the ability to consistently provide medical devices and services that meet customer and applicable regulatory requirements.

OBJECTIVES

Understand and implement the requirements to successfully achieve ISO 13485 certification.

TARGET AUDIENCE

Any professional involved in planning, implementing or maintaining an ISO 13485 QMS.

PREREQUISITES

None