Business Insider

Cellbox Solutions Submits Device Master File (DMF) to the U.S. FDA

Submission represents an important step towards establishing the Cellbox Live Shipment Technology as a new standard for warm chain logistic in the cell therapy sector Cellbox customers can now ...
MD&M East

Andersen Sterilizers Awarded First 510(k) Master File for EtO Sterility Change

In a major win for companies hoping to minimize the amount of ethylene oxide (EtO) needed to sterilize medical devices without the risk of 510(k) resubmission, Andersen Sterilizers and its contract ...
BioWorld

FDA introduces another sterilization master file pilot program

Seemingly in response to the release of a proposed rule for ethylene oxide emissions by the U.S. Environmental Protection Agency, the U.S. FDA has released a second pilot program for device master ...
Business Wire

Andersen Sterilizers & Andersen Scientific First Awardee in FDA’s 510(k) Ethylene Oxide Sterility Change Master File Pilot Program

HAW RIVER, N.C.--(BUSINESS WIRE)--Andersen Sterilizers and its sister company, contract sterilization specialist Andersen Scientific, were awarded the very first master file in the FDA's 510(k) ...
Morningstar

AIML Hits Key Regulatory Benchmark with 510(k) Filing for MaxYield(TM) Signal Enhancement Platform

This regulatory milestone builds on AIML's prior submission of a Device Master File (MAF) to the FDA. If accepted, the MAF may support future collaborations with manufacturers interested in ...