Medical Devices – Will EN ISO 14971:2019 be Harmonised with the EU MDR and IVDR or not?

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Medical Devices – Will EN ISO 14971:2019 be Harmonised with the EU MDR and IVDR or not?

EN ISO 14971 is arguably the most important of the all the Medical Devices standards as it concerns Medical Device safety and it forms a significant foundation for a number of other standards such as; EN 62366 (Usability), EN 62304 (Software Lifecycle), EN 60601 (Electrical Safe...

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Medical Devices – Update on Harmonised Standards for the MDR and the IVDR.

The EU has approved a revised Standardisation Request requesting the European standards body CEN to produce Harmonised Standards which will give a presumption of conformity to the European Medical Device Regulations MDR 2017/745 and IVDR 2017/746. CEN is now awaiting the officia...

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Medical Devices – Update on Harmonised Standards for the MDR and the IVDR

The EU has approved a revised Standardisation Request requesting the European standards body CEN to produce Harmonised Standards which will give a presumption of conformity to the European Medical Device Regulations MDR 2017/745 and IVDR 2017/746. CEN is now awaiting the official...

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Applying the Process Approach to a Quality Management System

Many people when they encounter the term process approach struggle to grasp an understanding of the term, and without this, the approach cannot be adequately followed. This article written by our expert Tutor, Liam Regan defines and outlines 10 steps on how the process approach c...

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