Wearable ECG Monitor: Regulations, Standards and Guidance

Wearable ECG monitors have changed the face of cardiac patient care. The device provides patients with mobility, increased freedom, convenience and ability to record ECG wi...

FDA – Medical Devices Advisory Committee

The U.S. Food and Drug Administration (FDA) has 31 advisory committees responsible for the evaluation and regulation of drugs, medical devices, and biologics. The advisory ...

Is EU-MDR coming later?

EU MDD to MDR - A major change 

Medical Device Directive (MDD) which is in action now and will sh...

Know the differences for proactive planning – MDD to MDR

The new Medical Device Regulation has been postponed by a year, however, the regulation is still coming and all medical device companies will be eventually expected to comp...