FDA announced this week a list of more than 1,000 medical devices that will now be exempt from 510(k) notification requirements — a move that aims to help speed up the process of bringing new medical devices to market. The decision was made this week in accordance with a process laid out by the 21st […]
Last week we discussed the extension the FDA has granted on the Unique Device Identifier (UDI) Class II Mandates. Similar to the extension there are also exceptions on single use devices that medical manufactures should be aware of. The exception states that if you put a (UDI) on the next higher level of packaging you […]
The Association for packaging and processing technologies, examined the latest trends impacting the pharmaceutical market. Global sales in 2016 have reached a record high for pharmaceutical sales at $1.1 Trillion, with North America alone generating $574 billion. The greatest influence on growth in the pharmaceutical industry is general economic development. As more people can afford […]
Companies worldwide are challenged with developing and maintaining efficient disciplined product labeling. They are tasked with a wide range of internal requirements, Marketing and Product Branding and external regulatory requirements, such as GHS or UDI compliance requirements. As example, the chemical industry and their respective supply chains are continuously evolving and have as complex a […]
When we talk about UDI in our industry, we always refer to the classes, Class 3, Class 2 and Class 1 UDI and we always reference the due dates. What gets lost in this discussion is the actual benefits that accompany UDI. When UDI is fully implemented there are benefits to multiple organizations: the organization […]
The healthcare industry has been rapidly preparing for FDA compliance requirements, on all medical devices (Class I-Class III.)— With the FDA’s latest deadline being completed for Class II devices this September, are you prepared for the Class I deadline? With each UDI deadline provide a new challenge for the medical device community. While many companies […]
A great blog post from Oracle (www.Oracle.com) with our CEO Paul Van Hout discussing how vital it was for our business to migrate to the cloud to ensure all ends of our business are reliable and efficient. Read more in the link below: https://blogs.oracle.com/midsize/small-business-big-technology