QUALITY MANAGEMENT FOR MEDICAL DEVICE END USERS, PRODUCERS, AND DEVELOPERS
ISO 13485 Reach
ISO 13485 certifications around the world reached 23,045 in 114 countries in 2019.
Medical devices in particular are subject to stringent customer requirements as well as various government regulations from country to country.
The processes applicable to the organization, but are not performed by the organization, are the responsibility of the organization and are accounted for in the organization’s quality management system by monitoring, maintaining, and controlling the processes.
FSEICC offer four different ISO 13485 courses.
Introduction, Foundation, Lead Implementer, and Lead Auditor
You can become an expert in navigating quality and regulatory environments for these critical products.
The standard opens ways to become more process efficient and in cutting costs.
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