{"id":32759,"date":"2024-07-01T09:08:42","date_gmt":"2024-07-01T07:08:42","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=32759"},"modified":"2024-07-01T09:22:11","modified_gmt":"2024-07-01T07:22:11","slug":"medical-devices-product-and-organisational-quality","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2024\/07\/01\/medical-devices-product-and-organisational-quality\/","title":{"rendered":"Medical Devices: Product and Organisational Quality"},"content":{"rendered":"

When discussing product quality, organisational quality cannot be ignored. In a total approach, quality extends to the entire company system, is the reference and objective for any activity and involves not only the quality division but all personnel, including every process and procedure, internal and external to the organisation, for the entire life cycle of the medical device. Thus, product quality <\/strong>is a direct consequence of organisational quality. <\/strong><\/p>\n

Medical device manufacturers <\/strong>can foster the growth of a quality culture <\/strong>in their environment by improving all processes and establishing an accurate and comprehensive control mechanism.<\/p>\n

To do this, one must first understand the basic principles, starting with the Medical Device Regulation MDR (EU) 2017\/745<\/strong>, which stipulates the mandatory implementation of a Quality Management System (QMS). <\/strong><\/p>\n

A further key reference is ISO 13485<\/strong>, an internationally recognised harmonised standard intended for use by any organisation involved in the design, development, manufacture, installation and servicing of medical devices or related services.<\/p>\n

Device Safety<\/strong><\/h3>\n

The concept of product quality inevitably recalls that of safety<\/strong>. How can the manufacturer market a quality device with evidence that its product does not endanger the patient or the user?<\/p>\n

In response, it is necessary to think of safety <\/strong>as a management <\/strong>and, therefore, system requirement<\/strong>, considering the incident <\/strong>no longer as the consequence of a single human error, but as the effect of an interaction between <\/strong>technical, usability, organisational and process factors. <\/strong><\/p>\n

In addition, manufacturers must design <\/strong>Medical Devices aiming at minimising operating errors <\/strong>and consequent damage, focusing in particular on the user interface.<\/p>\n

ISO 14971:2022<\/strong>, accompanied by ISO\/TR 24971<\/strong>, is the practical application guide to the standard that provides a framework for risk management of medical devices<\/strong>; the process described is intended to assist manufacturers in identifying hazards associated with medical devices, assessing and controlling risks, and monitoring the effectiveness of the process. The requirements apply throughout the life cycle of the medical device<\/p>\n

Device Clinical Evaluation<\/strong><\/h3>\n

In the clinical evaluation process, the manufacturer must demonstrate that its device is capable of achieving the expected performance <\/strong>during normal conditions of use and that known and foreseeable risks, together with any adverse events, are reduced to an acceptable minimum concerning the benefits of the expected performance.<\/p>\n

Within the design process <\/strong>there must be evidence of the processes <\/strong>of:<\/p>\n