ISO 13485 - Medical Devices Quality Management System

What is ISO 13485?

ISO 13485 is Medical Devices Quality Management System (MDQMS) which is designed for an organization to use throughout the lifecycle of medical device from initial design stage to ready product until associated services.

The latest version of ISO 13485 was launched in 2016 – ISO 13485:2016.

Who is ISO 13485 for?

ISO 13485 is applicable to all organizations which have related to medical devices, regardless of size or sector. It cover from design and development, to manufacturing, packaging, storage, delivery, distribution.

Process to get ISO 13485 Certification

ISO 13485 Applicable To Medical Devices Related Industry

Enquiry for ISO 13485 Certification Body

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