Medical device labeling: You need to design it, too

When designing and developing a medical device, companies often consider labeling down the road, but they shouldn’t, says Michael Drues, a regulatory consultant based outside Boston. Labeling can involve a variety of ways a medtech company markets a product. What Drues calls high-level labeling – indications for use, intended use and label claims – drives

FDA extends UDI compliance date for low risk devices

Labelers of class I and unclassified devices recently got a reprieve when FDA announced an extension of the compliance date for unique device identification (UDI). Makers of devices such as manual surgical instruments and mechanical wheelchairs will have 2 extra years to get these devices submitted to the Global unique device identification database (GUDID), FDA announced last

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

Tips for meeting the deadline: One month until U.S. FDA UDI compliance date for Class II devices

The compliance date for device labelers to place Unique Device Identifiers (UDIs) on their Class II devices is approaching quickly. Under the U.S. Food and Drug Administration (FDA) final rule, Class II devices must be labeled with UDIs starting September 24, 2016. FDA consulting firm Registrar Corp is providing tips to help labelers of Class

StepSERVO motors take on labeling and packaging for food and beverage

StepSERVO closed loop integrated motors with the Step-Servo Quick Tuner software and built in Q Programmer are well suited for labeling and packaging for food and beverage applications. StepSERVO integrated motors provide closed loop servo control of position, velocity and torque using high torque step motors. The result is higher acceleration for faster machine cycles, and

PDC Healthcare launches new Ident-Alert Tray and Scope Tags

PDC Healthcare, a developer of identification and patient safety solutions, announced that it has added a line of Ident-Alert Tray and Scope Tags to its product offering for hospital central sterile processing. Ident-Alert Tray and Scope Tags help central sterile processing personnel properly identify, classify and track trays, scopes and surgical instruments throughout the sterilization process

Roland MPX-90M Direct Part marking device

Marking surgical instruments and tools with unique device identification (UDI) numbers has never been more affordable than with the Roland MPX-90M direct part marking device. Unlike traditional dot peen technology, the MPX-90M is capable of accurately imprinting permanent two-dimensional DataMatrix barcodes as small as 1 mm2, on hard metals for product tracking and traceability. The

Omni-ID raises the bar with launch of next gen On-Metal RFID Label products

Omni-ID, a global supplier of high-performance, industrial IoT solutions recently announced the addition of five new products to its best-selling family of on-metal RFID labels. The IQ 100, the smallest global frequency, printable, on-metal label to hit the market, the IQ 150, IQ 300, the global frequency IQ 500 and an enhanced IQ 600 have been added to

Simple marking with TRUMPF’s TruMark 1110 and new TruMark Station 3000

TRUMPF Inc. showcased its TruMark 1110 in the new TruMark Station 3000 at the MD&M West event last month at the Anaheim Convention Center in Anaheim, CA. This diode-pumped vanadate laser is part of TRUMPF’s innovative and cost-effective series of entry-level marking lasers. It was featured with the new TruMark Station 3000, a compact marking station that offers users

Emergo whitepaper: Navigating labeling and symbol requirements in the European medical device market

A recent white paper published by Emergo discusses European rules regarding use of labeling and symbols for medical devices, and how electronic labeling as well as harmonization standards are impacting compliance under EU medical device and IVD directives. The EU recognizes more than 20 official languages, note white paper authors Jennifer Tribbett and Megan Gottlieb,