Medical device development end to end

Medical Device Development

Medical device development is a comprehensive series of well-coordinated activities and events from the moment of product concept and ideation, to risk assessme...

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 committee protects and...

Is EU-MDR coming later?

EU MDD to MDR – A major change 

Medical Device Directive (MDD) which is in action now and will shortly be superseded by Medical Device Regulations (MDR), had been practiced and...

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 comply with it in order to...