Medical Device Ce Marking Articles & Analysis
7 news found
AcuPebble SA100, a small wearable device that enables automated, remote home testing to detect obstructive sleep apnoea (OSA) in adults, has obtained FDA 510(k) clearance as a Class II medical device in the USA. The device, which received a CE Mark as a Class IIa medical ...
AcuPebble SA100, the first medical device to obtain the CE mark for the automated diagnosis of Obstructive Sleep Apnoea, has been announced as one of 12 exciting innovations to join the NHS Innovation Accelerator 2021. ...
Acurable, a fast-growing medical device company, has announced the availability of its first product, AcuPebble SA100, a small wearable device which for the first time enables a fully automated and remote diagnosis of obstructive sleep apnoea (OSA). ...
Healthcare professionals should be regularly trained to handle infective patients and pass through periodic screening for the virus. Dedicated medical air purifying equipment should be used for patient care and environmental infection control. The Chinese authorities combating the outbreak of Coronavirus (COVID-19) have built hospitals in the crisis areas and upgraded their ...
Waters Corporation (NYSE: WAT) today announced that the Waters® ACQUITY UPLC® I-Class IVD/Xevo® TQ-S micro IVD System is now manufactured as a U.S. FDA Class I medical device and is CE Marked to the European Directive 98/79/EC (IVDD). ...
As a worldwide leading Notified Body, BSI understands the challenges companies face when looking to broaden their employees’ knowledge and understanding of medical device regulations and standards. In fact, over 70% of the top medical device manufacturers worldwide are trained by BSI. ...
BSI, a world-class Notified Body providing regulatory and quality management reviews and product certification for medical devices, today announced the launch of CE-Dedicated FastTrack. This new CE marking program is designed to help medical device manufacturers get their ...