Iso 13485 Certification For Medical Devices

ISO 13485 is an International Standard that requires the quality management system within an organization to ably and consistently meet customer and regulatory guidelines relevant to the development of medical devices and related services. The primary objective of this International Standard is to facilitate a harmonized medical device regulatory framework for quality management systems.
ISO 13485 certification signals your companya s desire to not only comply with relevant European Union law regarding the sale of medical equipment to member countries, but also shows your organisationa s commitment to high quality product design and manufacturing procedures and the ability to adhere to industry recognised management standards.
ISO 13485 is an ISO Standard, published in 2003, that represents the requirements for a comprehensive management system for the design and manufacture of medical devices. It's the quality management standard specifically designed for organizations that provide medical devices or related services to ensure that customer and regulatory requirements are consistently met.

ISO 13485:2012 is the most recent iteration of the ISO 13485 quality standard for manufacturers of medical devices. This international standard applies to the design, development, production, installation and servicing of medical devices and related services.
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