iso 13485

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 manufacturersMedical devices & surgical  instrument manufacturers, Orthopadic Implant Design Consultantlaboratory equipment manufacturersSterilization Equipment and Accessories Manufacturers medical imaging systems manufacturers.

ISO 13485 Medical devices – Quality management systems – Requirements for regulatory purposes is an International Organization for Standardization (ISO) standard, publish for the first time in 1996. ISO 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 use 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 for ISO 13485:2016 that apply to the organization, but not performed by the organization, the responsibility of the organization and accounted for in the organization’s quality management system by monitoring, maintaining, and controlling the processes.

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.