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.
International Medical Development did not take adequate corrective and preventive actions for quality deficiencies at its Huntsville, Utah, plant, the FDA found in a Feb. 8-12 inspection. Read More
In the face of increasing cybersecurity threats, the Biden administration is taking several measures to implement stronger cybersecurity standards, including requiring software developers to maintain greater visibility in their supply chains and make security data publicly available. Read More
The European Commission has launched an online helpdesk for devicemakers who must comply with the new unique device identification (UDI) system introduced under the EU Medical Device Regulation (MDR), which went into effect on May 26. Read More
Validation issues, design control and inadequate corrective and preventive procedures were among the quality system failures cited in a warning letter to Wheat Ridge, Colorado-based DeChoker following a Feb. 17-26 FDA inspection. Read More
The FDA details its expectations for postmarket surveillance of moderate and high-risk devices in two draft guidances, including its criteria for ordering postmarket data collection. Read More
The FDA has studied how South Korea handled authorizations of COVID-19 diagnostic tests, hoping to learn from that country’s early success in dealing with the virus. Read More
Eurofins Export Services Oy of Finland has become the 20th notified body designated to certify device products in compliance with the EU Medical Device Regulation (MDR). Read More
A federal judge has issued a preliminary injunction blocking Charles River Laboratories (CRL) from harvesting the blood of horseshoe crabs for use in bacterial contamination tests for drugs and vaccines — a move that could lead to a shortage of the much-needed tests. Read More
The European Commission has proposed stiffer regulations for products that rely on artificial intelligence (AI) and some medical devices would be considered “high risk” under the proposal. Read More