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 […]
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 […]
Time and money are two of the most valuable assets in any business. Both of these can be wasted trying to solve incidents within your supply chain; whether its contacting multiple vendors, contacting support after hours, dealing with call centers. The list can go on; but there is a simple solution… Pragmatyxs Support. Pragmatyxs […]
A new era has begun for Gluten Free labeling standards; the FDA ruled a year ago that foods bearing the “gluten free” label would be held to certain regulatory standards and those rulings are now in effect. Any food labelled “gluten free” must contain less than 20 milligrams of the protein. Consumers can now confidently […]
Former FDA commissioner David M. Kessler is proposing the FDA extends their label regulations to the front of food packaging. With these regulations in place the consumer will be able to make more conscious decisions when selecting products that meet their needs. Also detailed in Kessler’s proposal is to aggregate related ingredients (i.e. sugar) to […]
Developers and researchers can now access and recalled drugs, medical devices as well as human and animal food product dating back to 2004.OpenFDA has created a weekly updated API that allows users to research any recalled product. Many of the recalls found in the report are product that have incorrect labeling or pose health and […]