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.

We also train the employees on the requirements of the quality system & channelize the system for continual improvement.We guide the clients through documentation & help them to effectively implement it through the various functions of the company.

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