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.
The UK’s Medicines and Health products Regulatory Agency (MHRA) has issued new guidance on how to register a device manufacturer or authorized representative with the agency in order to sell devices and IVDs. Read More
The FDA is delaying UDI rule requirements for soft contact lenses until one year after it resolves a technical problem — and the agency has granted a third extension for labelers of the lenses. Read More
Heater cooler units used in cardiopulmonary bypass and extracorporeal membrane oxygenation can generate potentially infectious aerosols containing a range of harmful bacteria, some of which can be fatal, according to an ongoing UK investigation. Read More