Loftware Blog / Medical Devices (2)

by Maureen Perroni, on November 20, 2017

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 …

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Topics:Medical DevicesRegulatoryLabeling

by Bob Brown, on November 16, 2017

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 …

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Topics:Medical DevicesAutomotiveSupply ChainManufacturing

by Laura Johnson, on November 7, 2017

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, …

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Topics:Medical DevicesHealthcareRegulatoryLabeling

by Craig Hodgson, on September 11, 2017

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 …

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Topics:Medical DevicesRegulatory

by Maureen Perroni, on August 3, 2017

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 …

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Topics:Medical DevicesRegulatoryLabeling

by Laura Johnson, on July 17, 2017

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 …

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Topics:Medical DevicesHealthcareRegulatoryLabeling

by Laura Johnson, on July 14, 2017

As companies continue to catch their breath after last year’s deadline to comply with the FDA’s UDI labeling requirements, the focus now turns to international compliance and adoption at the …

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Topics:Medical DevicesRegulatoryLabeling

by Craig Hodgson, on June 22, 2017

In contrast to last year’s UDI event, attendees at the recent UDI Conference in Baltimore seemed more positive and accepting of the regulation. Not that anyone has ever questioned the intent …

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Topics:Medical DevicesRegulatoryLabeling

by Craig Hodgson, on June 2, 2017

Billed as “the ONLY event dedicated to guidance and training for those impacted by the UDI Regulation,” the annual UDI Conference takes place next week on June 6-7 at the …

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Topics:Medical DevicesRegulatory

by Laura Johnson, on May 15, 2017

The FDA has adjusted UDI compliance deadlines several times. Compliance with the Food and Drug Administration's Unique Device Identification (UDI) system will be vital for medical device manufacturers in the years …

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Topics:Medical DevicesRegulatory

by Maureen Perroni, on May 12, 2017

Last week medical device professionals and solution providers gathered for Q1 Production's 6th Semi-Annual Medical Device Packaging and Labeling, at the Sheraton at Pentagon City in Arlington, VA to discuss labeling challenges and …

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Topics:Medical DevicesLabeling

by Maureen Perroni, on April 20, 2017

As medical device and diagnostic manufacturers continue to develop life enhancing products for patients across the globe, medical product labels and device packaging hold an increasingly important position to healthcare …

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Topics:Medical DevicesLabeling

by Laura Johnson, on April 17, 2017

Medical device regulations have received an update in Europe. Unique device identification (UDI) requirements are coming to Europe as part of the European Commission's latest legislation. The agreement has been in …

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Topics:Medical DevicesLife SciencesHealthcareRegulatoryLabeling

by Craig Hodgson, on March 31, 2017

As of April 29, 2017, all organizations within the European Union (EU)—as well as companies that do business in the EU—must have a single European code (SEC) or label on …

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Topics:Medical DevicesRegulatoryLabeling

by Craig Hodgson, on March 27, 2017

Keeping up with US and international UDI regulations. Battling increased complexity and the rising costs that go with it. Dealing with the growing pains of expansion or M&A activity. If …

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Topics:Medical DevicesSupply ChainRegulatoryLabeling