Tag

mhra
The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) announced it has recalled GE’s ApexPro telemetry server after multiple reported events of monitoring equipment not providing visual or audible alarms for ECG arrythmias, lead failures or SpO2 monitoring. The potential safety issues are: Patients can experience ECG arrhythmias before and after a “no telem” condition and...
Read More

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.