13485:2016 Standard: Medical Devices – Quality Management System – Requirements for Regulatory Purposes
Organizations have until March 1, 2019 to upgrade from ISO 13485:2003 to ISO 13485:2016.
The new edition of the ISO 13485 standard was published on March 1 2016, concluding almost five years of intense discussion and development by experts around the world to improve and update the standard with new European requirements and other international regulatory changes, implemented since its previous revision in 2003.
ISO 13485 defines the requirements for a quality management system designed to demonstrate an organization’s ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
Organizations complying with this standard, such as medical devices manufacturers, as well as suppliers and external parties that provide products or services to manufacturers, will be able to demonstrate compliance with regulatory requirements, manage risk, ensure best practice for quality and safety, improve processes and provide confidence to patients and users.
The new ISO 13485:2016 focuses on how companies should manage risk-based decisions related to purchasing, design, development, manufacturing, production control activities and other aspects of the quality management system.
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