ISO 13485:2016 – Medical Device Quality Management System

A Medical Device Quality Management System (QMS) is a structured system of procedures and processes covering all aspects of design, manufacturing, supplier management, risk management, complaint handling, clinical data, storage, distribution, product labeling, and more. Most medical devices will require some form of a QMS; the complexity of the QMS will vary based on the classification of the device. For example, companies making medium-risk (Class II) or high-risk devices (Class III) devices will require a different QMS implementation than companies making low-risk, non-sterile, non-measuring, non-reusable surgical instrument devices (Class I). We won’t get into the specifics of product registration or classification in this post, but you will want to understand the classification of your devices before building a QMS.

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