Loftware Blog / Medical Devices

by Dalton Litzelman, on October 17, 2019

In the health care sector, medical device labeling is one of the most essential processes in production. Any slight error in your labeling could pose risk towards your patients, and, …

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Topics:Medical Devices

by Guenther Martin, on October 10, 2019

The EU MDR and IMDR regulations are approaching implementation. The European Union is rapidly approaching the implementation date for a new set of regulations, the EU Medical Device Regulations, designed to standardize …

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Topics:Medical DevicesHealthcareRegulatoryTrack & TraceabilityGS1UDI

by Joe Farrell, on October 1, 2019

What are the regulations around medical device labeling around the world? Medical device labeling is one of the essential processes that goes into producing equipment for the health care sector …

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Topics:Medical DevicesHealthcareRegulatoryTrack & TraceabilityGS1UDI

by Josh Roffman, on September 18, 2019

UDI rules are expanding to Europe. Is your data storage and access infrastructure ready to comply? This article was originally published in MedTech Intelligence. The 2017 European Union Medical Device …

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Topics:Medical DevicesHealthcareLabeling

by Sam Ireland, on April 16, 2019

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 …

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Topics:Medical Devices

by Laura Johnson, on July 9, 2018

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 …

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Topics:Medical DevicesRegulatoryTrack & Traceability

by Craig Hodgson, on May 31, 2018

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 …

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Topics:PharmaceuticalsMedical DevicesSupply ChainRegulatoryFood & BeverageArtwork Management

by Craig Hodgson, on May 11, 2018

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 …

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Topics:Medical DevicesRegulatory

by Craig Hodgson, on May 4, 2018

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 …

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Topics:Medical DevicesRegulatoryLabeling

by Laura Johnson, on April 20, 2018

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 …

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Topics:Medical DevicesLife SciencesRegulatory

by Jay Crowley, on March 29, 2018

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 …

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Topics:Medical DevicesRegulatory

by Laura Johnson, on November 28, 2017

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 …

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Topics:Medical DevicesRegulatoryLabeling

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