What the EU Parliament’s Resolution Means for MDR and IVDR

The resolution represents a non-binding legal intention to consider further changes.

Staying on the compliant side of change control regulations

Medical device change control regulations have a lot of boxes to check.

New FDA Regulations for Laboratory Developed Tests (LDTs): What it Means to Laboratories

As IUD demand surges, CooperSurgical designs new Paragard placement system

5 tips for meeting new device packaging regulations before it’s too late

Noncompliance with European packaging waste directives mean fines or worse for device makers, so take this expert advice on designing for recyclability with innovative materials, testing and more.

Risk Management in Medical Devices: Harmonizing ISO 14971-2019 & FDA QMSR

nsuring the safety and efficacy of medical devices/IVDs is paramount in the healthcare industry. This critical objective is achieved through comprehensive risk management practices, and two key frameworks play a crucial role: ISO 14971:2019 and the FDA Quality Management System Regulation (QMSR). This essay explores their individual contributions and how they work synergistically to enhance medical device safety.

Transitioning EU Clinical Trials: Key Steps for Compliance by 2025

To streamline processes, enhance transparency, and improve the overall efficiency of conducting clinical trials in the EU/EEA, the 3-year transition period from the CTD to the CTR requirements was established. With the end of the transition period approaching, all ongoing clinical trials that were approved under the CTD will have to be fully be transitioned to comply with the CTR. Failure to comply by 2025 will bring serious consequences.

2024 Medtech FDA Approval Volume Trends Down

FDA updates device shortage list and permanent discontinuance list

The FDA has removed AEDs from its device shortage list but added blood culturing systems. It also added six permanently discontinued devices to its list, including AEDs made by Philips and infusion pumps made by Fresenius Kabi. The agency no longer requires manufacturers to report shortages but encourages voluntary reporting.

That Time FDA was ‘Unusually Thorough’ on a Form 483

What medical device company was hit with a 54-page Form 483 documenting its perceived shortcomings in 2016?