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Home » Topics » Medical Devices » Quality

Quality
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CDRH Provides New Online Resources for UDI Program

April 12, 2016
The FDA has added five new modules to its CDRH Learn online platform covering the Unique Device Identification program. Read More

HELP Committee Unanimously Advances Scope Safety Bill

April 1, 2016
The Senate HELP Committee unanimously advanced to the full Senate a bill that would give the FDA additional tools to review and ensure the safety of medical devices, such as duodenoscopes. Read More

Expert: ISO 13485 Could Conflict With Quality System Rules

April 1, 2016
Changes in the new ISO 13485 may conflict with many of the requirements in FDA’s quality system regulation. Read More

Standard on Small-Bore Connectors Focuses on Neuraxial Applications

April 1, 2016
Aiming to improve the safety of medical device connections in clinical settings, ISO has published a new standard on neuraxial applications for small bore-connectors. Read More

Verathon Announces Recall of Video Laryngoscope

March 21, 2016
The FDA has labeled the recall as Class 1. Read More

Physio-Control Announces Recall of AED Electrodes

March 18, 2016
The company is asking customers to quarantine and return any unused products. Read More

Muddying the Waters: New Standard May Hinder QMS Implementation

March 4, 2016
Changes in the new ISO 13485 may conflict with many of the requirements in FDA’s quality system regulation. Read More

Expert: ISO 13485 Could Cause Confusion With FDA’s Quality System Regulation

March 3, 2016
Changes in the new ISO 13485 may conflict with many of the requirements in FDA’s quality system regulation. Read More

Expert: ISO 13485 Keeps Eye on Quality, But Revisions Could be Problematic

February 26, 2016
The revised ISO 13485 is intended to maintain non-negotiable levels for quality and safety requirements, but one expert says the standard has gone too far in an attempt to satisfy everybody involved in quality management systems. Read More

FDA Introduces New precisionFDA Online Portal for NGS Analysis

February 19, 2016
The FDA is hoping to improve the quality and accuracy of genomic tests through the launch of a new online portal that will allow for collaboration on developing the science behind next-generation sequencing. Read More

Expert: Prepare for Investigators on Software Verification, Validation

February 4, 2016
The FDA has hired a team of tough new investigators to crack down on medical devicemakers whose software doesn’t measure up in terms of verification and validation (V&V). Read More

Ireland Launches National eAlert System

January 29, 2016
To help prevent recurrences of medical device-related adverse events, Ireland has launched a national eAlert system intended for healthcare facilities. Read More
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