Med Device Online1d
U.S. Deregulation During The Trump Administration: Opportunities And Challenges For The Global Medical Device Industry
The medical device sector faces significant changes, as both Donald Trump and Robert F. Kennedy Jr. have identified the FDA ...
medtechintelligence1d
CMMS Software: Enhancing Regulatory Compliance
Computerized Maintenance Management System (CMMS) software can be a vital tool for life sciences manufacturers in maintaining ...
medtechintelligence1d
How will deregulation in the US affect the international medical device market?
The United States is currently under the spotlight as Donald Trump’s recent appointment and consequent nomination of Robert F ...
medtechdive1d
Few medical devices are designed for children. An FDA-Children’s National collaboration aims to change that.
Kolaleh Eskandanian, chief innovation officer at Children’s National Hospital, said the partnership is meant to address the ...
JD Supra3d
FDA Sued Over Laboratory Developed Tests Final Rule
The Food and Drug Administration (FDA) is being sued in two lawsuits after releasing its Final Rule on Laboratory Developed ...
Strong Growth In The Indian MedTech Industry And Global Recognition Of FDA 510(K)
Explore the rapid growth of the Indian MedTech industry and the importance of FDA 510(k) clearance for global expansion.
JD Supra4d
FDA's Digital Health Advisory Committee Discusses Total Product Lifecycle Considerations for GenAI-Enabled Devices
While generative artificial intelligence ("GenAI") has the potential to fundamentally change health care, it presents unique risks and ...
theregreview6d
Evolving Regulatory Protections for Research Participants
In a conversation with The Regulatory Review, Ropes & Gray partner David Peloquin discusses how clinical research studies are ...
US FDA Inspection on Rise: Indian Pharma and Medical Devices Manufacturers Strengthen GMP Compliance
In a significant step toward ensuring global quality standards, Indian pharmaceutical, nutraceutical, and medical device ...
Are The FDA’s New Regulations On Medical Devices Making A Difference?
With the FDA's new requirements for premarket submission and ongoing monitoring by medical device manufacturers in place, ...
medtechdive14d
BD receives FDA warning letter over quality system violations
Inspectors found 111 open tickets for software defects categorized as catastrophic or severe patient harm. Several safety ...
Merit Medical Announces FDA Approval of the WRAPSODY Cell-Impermeable Endoprosthesis
Unique cell-impermeable1 design extends life-saving treatment for dialysis patientsMerit to host a WRAPSODY informational call on January 28, ...