ISO 13485

ISO 13485:2016 for medical devices

Description

ISO 13485:2016 is an internationally recognized standard for quality management systems specifically adapted for medical device companies. It is designed to support companies and organizations involved in the design, production, installation and service of medical devices and services. The standard emphasizes the importance of meeting regulatory and customer requirements, and is intended to be used by both internal and external parties, including certification bodies, to ensure consistent quality and safety of products.

The standard covers all aspects of quality assurance, including requirements for management responsibility, resource management and product realization. This standard also helps to clarify and strengthen the link with the EU Medical Device Regulation (MDR), which is crucial for companies striving to meet the latest regulatory requirements within the EU. By following ISO 13485, medical device companies can not only improve their internal processes but also strengthen the confidence of their customers and regulatory authorities.

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