Loftware Blog / Medical Devices

UDI rules are expanding to Europe. Is your data storage and access infrastructure ready to comply? The 2017 European Union Medical Device Regulation (MDR) deadline of May 26, 2020 is …

If so, you won't won't want to miss this year’s European UDI Forum, taking place in Brussels, April 24-25. Loftware will be a sponsor at this year's event, which provides an opportunity for leaders from …

Medical device labeling requirements around the world are intensifying. As regulations continue to go into effect around the world, compliant and up-to-date medical device labeling has become an essential element …

Heading to GS1 Connect next week in Phoenix? This annual event brings together key influencers and decision makers from Foodservice, Healthcare, Retail Grocery and Apparel to network and participate in …

Labels continue to play a critical role in the safe testing, manufacturing, distribution and use of medical devices worldwide. Not only must they comply with a range of regulatory requirements …

Just as you’ve come to grips with the FDA’s Unique Device Identification (UDI) system, along comes the European Union’s version—and a new set of labeling requirements. The EU’s recently published …

Just as medical device companies have achieved a comfort level with their labeling programs to ensure compliance with the FDA's Unique Device Identification (UDI) system, along comes Europe's version of UDI with …

On January 12th, FDA published an immediately-in-effect (IIE) guidance document titled “Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices,” (available here). The guidance states that …

Just when you thought you had a good grasp—or at least a reasonable understanding—of the FDA’s UDI system and its associated labeling requirements, along comes the EU’s Medical Device Regulations …

Welcome back to the Loftware blog. Today we'll continue discussing the many complex regulations manufacturers must follow when labeling sensitive products for use around the world. Medical devices are one of …

Scale of production brings new challenges. Producing items at a high volume can bring challenges different from those associated with small-scale efforts, even when manufacturers are dealing with the exact same …

UDI labeling calls for effective data management. Manufacturers of medical devices have to deal with rules and regulations unique to their sector, and with good reason: If anything goes wrong, …

This month, Sept. 24th to be exact, is the FDA deadline for labelers of soft contact lenses to comply with the Unique Device Identification (UDI) system for class II and III soft …

Labeling can be challenging and today’s medical device manufacturers are faced with a range of evolving requirements and regulations such as UDI, that complicate the process. But labeling can make …

Medical device identification deadlines are moving targets. The medical device production field, bound by its unique rules and regulations, is a challenging space for manufacturers to inhabit. For the past …