ISO 13485

Medical device quality management system certification coaching

 

Enhance the product value and company image of medical device manufacturers, and have the advantage of entering international sales and obtain important certifications for competitiveness.

 

Medical Devices - Quality Management System - Regulatory Requirements. The quality management system standards established for the medical device industry help medical device manufacturers establish company standardized processes, including the design, development, manufacturing, installation, and service of medical devices. The latest version of the standard was officially released in March 2016. The new standards will apply to the entire medical device supply chain and will be more relevant to suppliers of spare parts and services. This revision focuses on medical device safety assessment and puts more emphasis on the concept of risk management. In addition, it also stipulates that the scope of quality control extends to the entire life cycle of the product (including post-market surveillance).

In order to meet the requirements of medical device manufacturers, MedServ provides customized guidance, introduces the core of operations, and controls the value of complete medical device safety and effectiveness.

 

MedServ provides comprehensive and rapid guidance to medical device manufacturers. Welcome to consult at any time.

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