We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
One aspect of document management systems is maintaining an audit trail of electronic records. Maintaining an audit trail protects the authenticity, integrity and, when appropriate, the confidentiality of electronic records. Read More
The global market for smart medical devices will increase at a compound annual growth rate of 14.6 percent through 2026, to a total of $286 billion in 2026 from $110 billion in 2019, according to an analysis by ResearchAndMarkets.com. Read More
In a final order published yesterday, the FDA reclassified general laparoscopic power morcellation containment systems as class II medical devices requiring “special controls,” including specified training, labeling and a boxed warning. Read More
The World Health Organization (WHO) and the Medicines Patent Pool (MPP) announced Tuesday they have reached a licensing agreement with the Spanish National Research Council for a COVID-19 antibody test that they will make freely available. Read More
It is all too easy for a consumer or healthcare professional complaint about a drug or device to snowball into a nightmare of damaging publicity, recalls, regulatory fallout and even lawsuits from customers and shareholders. Prompt, careful and correct responses to complaints can mean the difference between a company avoiding these landmines or picking up the pieces after the explosion. Read More
Elizabeth Holmes is testifying this week in her own defense in her trial for fraud connected with the failure of Theranos, the blood testing diagnostics company she helped found. Read More