International – Strategies to Prevent Component Shortages During a Crisis

COVID-19’s impact on manufacturing has created a number of business roadblocks, including order cancelations, large fluctuations in demand, supply chain issues, and reduced production...

International – EU OKs coronavirus test from Macrogen

South Korea’s Macrogen has received a CE mark for a new coronavirus test kit, Axen COVID-19 RT. The test confirms if a patient is infected...

International – 10 steps to conducting a use-related risk analysis as part of your...

Use-related risk analysis (URRA) is a cornerstone activity for a thorough human factors engineering (HFE) process that meets the expectations set forth by US...

International – Researchers develop prostate cancer blood test

A new blood test for prostate cancer is producing a 99% accuracy rating—precision that has never before been achieved for a blood test of...
ISO 14971 :2019 - GAP-ANALYSIS résumé versus l’ancienne version ISO EN FR 14971 : 2013.

International – ISO/TR 20416:2020 – Surveillance après mise sur le marché incombant aux fabricants

Le présent document fournit des recommandations relatives au processus de surveillance après mise sur le marché et est destiné à être utilisé par les...
FDA, MHRA Officials Stress the Criticality of Data Integrity in Clinical Trials

International – Demonstrating medical device cyber risk management to regulators and clients

“My medical device doesn’t have network or wireless connectivity, so cybersecurity regulatory requirements don’t apply, correct?” We get this question quite often during initial...

International – Recasting CAPA as a continuous improvement process

This article summarizes a white paper developed by the Medical Device Innovation Consortium (MDIC) under the case-for-quality program. The white paper recasts the corrective...

International – (CFR) 21 part 820.30 : Design verification and validation versus human factors...

In the complex world of medical device regulation, it can be difficult to keep things straight when it comes to product development. Different methods...
ISO 14971 :2019 - GAP-ANALYSIS résumé versus l’ancienne version ISO EN FR 14971 : 2013.

International – ISO/TR 24971:2020 – Guidance on the application of ISO 14971

This document provides guidance on the development, implementation and maintenance of a risk management system for medical devices according to ISO 14971:2019. The risk management process can be part of a quality...

International – How regulators have adapted globally to clinical trials for drugs and biologics...

The COVID-19 pandemic has disrupted clinical trials globally and has resulted in a 65% worldwide decrease in new patient enrollment year-over-year during March 2020....

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