Category: Medical Device

Why is Medical Technology Getting Shrouded by the Fear of Cybersecurity Issues?

November 22, 2019
Medical Device

Cybersecurity threats top the list when it comes to imminent dangers surrounding the healthcare industry. Every technologically driven device has a high chance of security breach and the main reason...

Labeling Requirements for Medical Devices

November 21, 2019
Medical Device

Labeling acquires a major part when it comes to ensuring the safety of those that are using it. The leading international standard ISO 13485:2016, pertaining to the quality systems of medical devices...

cosmetics, EU medical devic, FDA medical device, Labeling, Medical Device

USA: FDA Modifies List of Standards for Premarket Device Reviews

October 25, 2019
Medical Device

The US Food and Drug Administration (FDA) modified the list of standards to assist medical device manufacturers that elect to declare conformity with consensus standards to meet certain requirements....

USA: FDA Drafts Guidance on Patient Engagement in Device Trials

September 27, 2019
Medical Device

The US Food and Drug Administration (FDA) has published draft guidance on how device manufacturers should engage patients when designing medical devices. This Draft Guidance is Intended...

China: NMPA Joins IMDRF’s Post-Market Device Safety Data Exchange Scheme

September 27, 2019
Medical Device

The China National Medical Products Administration (NMPA) has joined the International Medical Device Regulators Forum’s (IMDRF) national competent authority report (NCAR) exchange program. NCAR supports...

Uncertainty as a Factor in Determining Benefit-Risk for Pre-market Approval of Medical Devices

September 5, 2019
Medical Device

With the recent announcement from FDA’s Center for Devices and Radiological Health (CDRH) about their finalization of guidelines towards accepting a higher premarket uncertainty with regards to the...