Blog Category: Medical Device

Medical Device Post Market Surveillance

Medical Device

Post-market surveillance (PMS) systems play a critical role in monitoring medical device safety and performance after they reach the market. Effective PMS helps reduce costs, minimize resource demands,...

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

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

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 device, FDA medical device, Labeling, Medical Device

USA: FDA Drafts Guidance on Patient Engagement in Device Trials

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The US Food and Drug Administration (FDA) has published draft guidance on how device manufacturers should engage patients when designing medical devices. This Draft Guidance is Intended...

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

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...

European Medicines Agency Seeks Public Opinion on Draft Guideline on Quality Requirements for Medical Devices

Medical Device

European Medicines Agency has released a draft guideline on the quality requirements for medical devices in human medicines that include a medical device, known as drug-device combinations, for a 3-month...