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WHO Malaria RDT Product Testing Round 2 Jan 7th 2009 Dear Manufacturer, WHO Malaria RDT Product Testing and ISO 13485:2003 and ISO 9001: 2000 certification TH As previously stated, a current ISO 13485:2003

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What is iso 13485 and iso?

ISO 13485 is an international standard for the design, development, and production of medical devices. ISO, shortened for International Organization for Standardization, is an independent, non-governmental international organization that develops and publishes standards.

Who is required to file iso 13485 and iso?

ISO 13485 certification is not something that needs to be filed, but rather obtained by medical device manufacturers and suppliers who want to demonstrate their commitment to quality and regulatory compliance. ISO certifications are voluntary and not mandatory by law.

How to fill out iso 13485 and iso?

ISO 13485 is not something that needs to be filled out, but rather complied with by medical device manufacturers. The process of achieving ISO 13485 certification involves implementing a quality management system that meets the requirements of the standard, undergoing an audit by a certification body, and gaining certification upon successful audit.

What is the purpose of iso 13485 and iso?

The purpose of ISO 13485 is to establish a quality management system for medical device manufacturers that ensures compliance with regulatory requirements and demonstrates their ability to consistently produce safe and effective medical devices. ISO standards, in general, aim to facilitate international trade, improve product quality and safety, and foster innovation.

What information must be reported on iso 13485 and iso?

ISO 13485 does not require specific reporting of information. Instead, it outlines the requirements for implementing a quality management system, which includes documentation of processes, procedures, and controls related to design, development, production, and post-market activities of medical devices. The exact information to be documented and reported will depend on the specific requirements of the medical device and applicable regulations.

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