ISO 13485
Optimize ISO 13485 Management
StandardFusion enhances ISO 13485 compliance by centralizing the management of quality processes, automating compliance tracking, and ensuring that your organization meets stringent regulatory requirements for medical devices, thereby improving product quality and safety.
ISO 13485 Standard
Publisher
International Organization for Standardization
Date Published
2016
Category
Quality Management
Description
The ISO 13485 standard specifies requirements for a quality management system (QMS) in the medical device industry. It is designed to ensure that organizations consistently produce medical devices that meet both customer and regulatory requirements. ISO 13485 covers all aspects of the product lifecycle, from design and development to production, installation, and servicing, ensuring the highest levels of quality and safety.
Overview
ISO 13485 is intended for organizations involved in the design, production, installation, and servicing of medical devices. Its purpose is to ensure these organizations implement and maintain a robust quality management system that consistently meets regulatory and customer requirements for medical devices.
