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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...

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...

Implementing ISO 14001 & ISO 50001 – Similarities & Differences

In this blog series our expert Tutor in Environment and Energy, Liam Regan investigates the similarities and differences between ISO 14001: 2015 and ISO 50001:2018. The intent is to help organisations who are looking to get certified to either one or both of these standards to ga...

Is Analysis of Multiple-Fault Conditions a Requirement of ISO14971?

The above question was posed by one of the delegates at a recent Quality Risk Management and ISO 14971:2019 virtual training course delivered by our expert Tutor John Lafferty John reviews the requirements for Single-fault and Multiple-Fault conditions in ISO 14971, the EU MDR/IV...

6 Reasons why Benefit-Risk Analysis is required for Individual Risks under the MDR

Written by Expert Tutor and Industry Expert John Lafftery in response to his post on “What is the Difference between the EN and ISO versions of 14971:2019 Part 2?” The following query came from a reader; “Where does it say in the MDR that benefit-risk analysis i...

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