A product issue could lead to serious health consequences, including loss of consciousness, bleeding, fluid buildup around the heart and death.
One ill-prepared EO can impact the entire supply chain.
The goal of the guidance is to ensure that manufacturers are prepared to report adverse events during a pandemic.
The continued threat and spread of COVID-19 across the globe has led to seismic uncertainty for every industry.
The manufacturers failed to comply with requirements related to post approval studies and good manufacturing requirements, respectively.
The Abbott ID NOW test may return false negative results.
Smart process automation promises to cut complexity and transform product traceability in the medical device industry. However, its potential relies 100% cent on having good, reliable data on which to draw.
Don’t miss this opportunity to learn how your company can effectively push its product to the finish line.
A recap of a recent effort involving a small group of AIDC experts in devising a data integrity scheme suitable for protecting a new device identifier used in modern healthcare applications against mis-keying. It presents the group’s undertakings in researching solutions to ensure identifier integrity, the challenges encountered, and how a more complete understanding of the constraints of the intended application led to a departure from the initial design and resulted in the elegant solution that exists today.
The prescription-only diagnostic allows patients to self-collect saliva samples to test for SARS-CoV-2.
