Software is a top cause of medical device recalls: Here’s what you can do

Stericycle Expert Solutions recently conducted a five-year assessment of recall trends, based on its quarterly Recall Index studies. The results show surprising missteps from medical device companies, especially where software is concerned. We asked Chris Harvey, director of recall solutions at Stericycle to answer some questions about the recall trends and offer some advice on

How laser marking could solve the medical device industry’s UDI challenges

Here are five ways that laser marking could provide advantages to medical device companies when it comes to meeting permanent marking requirements under FDA’s Unique Device Identification program. Ashir Thakore, SABIC As the U.S. Food and Drug Administration (FDA) implements its phased Unique Device Identification (UDI) program across medical device classes, OEMs are considering methods

FDA publishes final guidance for UDI direct marking requirements

David Lennarz, Registrar Corp. The U.S. Food and Drug Administration (FDA) requires devices intended to be reprocessed or devices intended to be used more than once by multiple patients to physically bear a permanent unique device identifier (UDI) marking that lasts the duration of the devices’ expected lifetime. This is known as UDI direct marking. The

Better medtech UDI management could be an app away

Boston-based 121nexus said it can solve UDI supply chain master data problems through image recognition technology. Experts say the best apps on the market are “peace of mind” apps. 121nexus aims to deliver that feeling with its scanner. The company launched a free scan app that can verify and “open up” GS1 and unique device

UDI laser marking: Here’s the key to making it durable

Optimized lasers and passivation can make the difference when it comes to creating durable UDI laser markings for medical devices, according to a new long-term case study. Tuttlingen, Germany–based Add’n Solutions, worked with FOBA Laser Marking+Engraving to test the marking processes. The results found that FOBA’s short pulse fiber making lasers worked better when optimized to adapt to

Here are the top 5 medtech stories of mid-2017

The middle of 2017 is shaping up to be a continued whirlwind of activity for medtech. FDA is getting used to its new leadership but is facing a continued lack of clarity on user fees and UDIs. Industry is seeing a deeper consolidation in medical supplies, exemplified in Cardinal Health’s purchase of patient recovery supplies from

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This Trumpf laser could solve your UDI compliance problems

Trumpf is touting a new laser and software module that enables UDI marking from a single source. Medical device makers can create corrosion-resistant marks on highly reflective materials using ultra-short pulsed lasers. By combining a marking laser with a UDI software module, Trumpf offers both components from a single source. This helps manufacturers to comply with

How Atlas Vac Machine plans to gain on UDI

Atlas Vac Machine, a maker of medical tray and blister sealers, has added new features to its equipment to better aid medical device companies trying to keep up with FDA’s Unique Device Identification rules. Over the past year, the Cincinnati-based company has had its machines providing data logging of operator IDs and passwords, sign-ins, PW