2020-05-27T13:05:54
ISO 13485 consultancy services for ISO 13485 Medical Devices Quality Management Certification in Baddi, Himachal Pradesh.
ISO 13485:2016 identifies needs for a quality management system where an organization requirements to demonstrate its capability to offer medical devices and related services that constantly meet client and applicable regulatory needs. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and improvement or provision of associated activities (e.g. technical support). ISO 13485:2016 can also be used by dealers or external parties that deliver product, including quality management system-related services to such organizations.
The standard offers manufacturers, designers, and suppliers to the medical device industry with the framework required to demonstrate compliance to regulatory requirements, mitigate risks, and confirm best practices are taken for quality, safety, and sustainability.
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