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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
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
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
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
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
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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