India’s Ministry of Health and Family Welfare has proposed amendments to the Medical Devices Rules 2017 that will shorten ...

In June, Brazils ANVISA released a batch of clinical trial petitions because its review deadline had expired without a ...

The Dual Seal Variable Volume Precision Dispense Pump is a robust, stepper motor-driven positive displacement pump designed for reliable dispensing of complex fluids, including those with high ...

PRISYM 360 is the ONLY labeling solution dedicated to Medical Device and Life Sciences. PRISYM 360 provides organizations with complete label integrity to meet the strictest compliance requirements ...

Artificial intelligence (AI) and machine learning (ML) are redefining healthcare, from enabling earlier diagnoses and personalized treatments to streamlining hospital operations and accelerating ...

The FDA proposed on Feb. 22, 2022, an update to the Quality System Regulation 1 that was released in 1996. The proposal is to reference ISO 13485:2016 Medical devices — Quality management systems — ...

Periodically, standards are revisited by international and national committees to determine if they are still current or need revision or withdrawal. Through the voting process and based on comments ...

The majority of IV infusions are performed in acute care settings, such as hospitals and other out-patient centers. 1 Infusion of medication is a common form of treatment in hospitals across the ...

In 2023, the FDA made the electronic Submission Template And Resource (eSTAR) mandatory for most 510(k) submissions. Although eSTAR is not an AI tool, the move was the first definitive leap toward the ...

The EU Medical Device Regulation (MDR) has significantly raised notified body expectations of the level and quality of clinical data for medical devices. For this reason, an equivalence strategy can ...

The U.S. Food and Drug Administration (FDA) has issued its much-anticipated final guidance on cybersecurity risk management in medical devices, effective June 2025. This document, titled ...

The current economic climate is characterized by a broad-based and sharper-than-expected slowdown, with inflation higher than seen in several decades. The cost-of-living crisis, tightening financial ...