A great article from Med Device Online regarding the recent and upcoming changes to UDI compliance. These new regulations coming into affect will ensure proper information and identification is attainable to the consumer for proper use and understanding of the product. To view the full article click the link below: http://bit.ly/1DwOK0S
Due to the overwhelming demand for updates to ISO 13485 which regulates medical device compliance; we expect to see some important changes by quarter 1 of 2016. The biggest revision expected is the compliance with international regulations; ensuring consumers that these devices have been tested and meet all safety requirements across the globe is […]
Today’s consumer has become more informed and enlightened regarding the products they purchase, where they come from, what they are made of, and, most importantly, if they are safe. Product recalls when not handled properly can erode customer trust and result in costly litigation, a tarnished reputation and ultimately lost revenue. Traceability plays two very […]
The FDA’s ruling for medical devices to carry a UDI (Unique Device Identification) will go into effect on September 24th. This will allow easy and definitive attributes of a medical device reducing errors in misidentification or improper use. Making these necessary can be a costly task for companies who aren’t prepared. That is where Pragmatyxs […]
We are excited to introduce a new segment in our blog : Tips & Tricks! The technology industry can be complicated and hopefully we can share some insight to make your life a little easier. Our first Tips & Tricks segment comes from a case study done by Barcode-Test.com; read the full article below and […]
The openFDA project is a database that allows researchers and developers access to countless reports on food, drugs and now medical devices. openFDA has now added MAUDE (Manufacturer and User Facility Device Experience); a database with reports on devices such as prosthetics, heart valves and robotics dating back to the early 1990’s. To view the […]
FDA NEWS RELEASE For Immediate Release: Sept. 20, 2013 Media Inquiries: Synim Rivers, 301-796-8729, synim.rivers@fda.hhs.gov Consumer Inquiries: 888-INFO-FDA FDA finalizes new system to identify medical devices Rule will help to improve patient safety Today, the U.S. Food and Drug Administration announced a final rule for the unique device identification system (UDI) that, once implemented, will provide a […]