ISO 13485 Consultant For Medical Devices:

ISO 13485 is a quality management system specifically developed for medical devices & related services. ISO 13485 can also be used by suppliers or external parties that provide the product, including quality management system related services to such organizations.

Operon Strategist helps clients develop, implement & maintain an efficient quality management system. We do an initial gap analysis of the existing system to determine the extent of development of the quality system.

We Are Regulatory Project Consultant Service provider for Medical Device disposable implant manufacturers, Medical Disposable syringe manufacturers , Medical devices & surgical  instrument manufacturers, Orthopadic Implant Design Consultant , laboratory equipment manufacturers , Sterilization Equipment and Accessories Manufacturers , medical imaging systems manufacturers.

ISO 13485 Medical devicesQuality management systems – Requirements for regulatory purposes is an International Organization for Standardization (ISO) standard, was published for the first time in 1996, that represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices. This standard supersedes earlier documents such as EN 46001 and EN 46002 (both 1997), the previously published ISO 13485 (1996 and 2003), and ISO 13488 (also 1996).

ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system -related services to such organizations.

Requirements of ISO 13485:2016 are applicable to organizations regardless of their size and regardless of their type except where explicitly stated. Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the organization.

The processes required by ISO 13485:2016 that are 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.


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