Test and Measurement: Regulatory Updates and Strategic Implications

Medical device companies are operating in a climate of rapid transformation. The traditional regulatory and testing frameworks that have guided development for decades are evolving, prompted by technological innovation, increased globalization, and lessons learned during recent public health challenges.

The Critical Role of Supply Chain Visibility for Post-Market Surveillance

In recent years, medical device regulators have implemented stricter requirements for post market surveillance (PMS), as seen in frameworks like the EU Medical Device Regulation (MDR), the In Vitro Diagnostics Regulation (IVDR), and the UK’s Statutory Instrument (SI) coming into effect on June 16, 2025.

How Early FDA Engagement Can Accelerate Medical Device Approval & Reduce Market Delays

By interacting with FDA as early as medical device conception, and taking advantage of one or more FDA programs, manufacturers can shorten their time to market and significantly reduce expenditures.

From the Editor – FDA’s Final Rule on LDTs Raises Concerns for Personalized Medicine

Arecent report from data and analytics firm GlobalData finds that FDA’s final rule on laboratory developed tests’ (LDT) hampers innovation and puts the future of these devices in limbo. With the FDA’s final rule on LDTs on the horizon, clinical laboratories, manufacturers, and patients have raised concerns about its potential impact on the U.S.

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

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

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

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

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?