ProMedic is pleased to announce the hire of Nichole Leahy-Glass. Nichole provides technical consulting services in Quality Management Systems. During her career, she has had several specific roles throughout the medical device life-cycle including Design Engineer, Quality Engineer, RA/QA Specialist, and Subject Matter Expert for Medical Device Start-ups and mid-sized…
Read moreFMMC Annual Symposium – ProMedic Exhibiting
The 2017 Florida Medical Device Symposium will be held May 8-9, 2017, at the Hilton Carillon Park in St. Petersburg. The symposium is Florida's premier event for medical device manufacturing firms, featuring nationally recognized speakers, expert panels on regulatory issues and industry trends, legislative updates and quality networking opportunities. The…
Read moreTarget-Controlled Infusions: Paths to Approval
Recently, Paul Dryden, President of ProMedic, authored an article regarding TCI. The purpose of this special article is to explore possible regulatory paths that could lead to TCI marketing clearance or approval by the FDA, permitting clinical use of this widely available technology in the United States. The article can…
Read moreFDA Launches Public Access to the GUDID
On May 4, 2015, FDA launched a publicly available Global Unique Device Identification Database. This new search function can be found HERE. This website allows any person to search or download information that device labelers have submitted to the GUDID about their medical devices. The public GUDID search function is…
Read moreUDI – What can you do today to get prepared?
With the UDI final rule passed and implemented, many companies are still unfamiliar with the UDI requirements. This is a difficult and arduous process that takes a dedicated team and lots of planning. However, compliance can be achieved by starting off on the right foot. Here is a short list…
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