Class II - General controls with special controls

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

Dutch Mellon Medical unveils major innovation in surgical suture technology: Single-handed suturing using the Switch

Mellon Medical is unveiling a patented ground-breaking global innovation in suturing technology. The company has developed a platform technology for suturing with a single hand. The Switch, a disposable precision-suturing instrument, enables surgeons to suture tubular and layered structures about twice as fast as the conventional technique. The technology is expected to reduce the risk

Medical Murray adds clean room space in two facilities

Medical Murray, a device development and contract manufacturing company with ISO 13485 certification and FDA registration, has expanded clean room capabilities in their Illinois manufacturing facility and North Carolina location. The additions come less than a year after Medical Murray purchased their Lake Zurich, Ill., 44,000 square-foot manufacturing facility, and built a larger 10,000 square-foot

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

ResolutionMD is registered for web and mobile diagnosis in Costa Rica

Calgary Scientific, a company known for creating innovative technology for the medical industry and beyond, announced that ResolutionMD medical imaging software is registered by the Ministry of Health in Costa Rica for diagnosis using both web and mobile devices. The Costa Rican Ministry of Health regulates the healthcare industry and acts as the regulatory agency

Proven Process chosen by Modus Health to manufacture class II medical device

Proven Process Medical Devices Inc., a global leader in the design, development, validation, and manufacture of Class II and Class III medical devices, announced today it has been selected to manufacture StepWatch, a Class II, scientifically validated, highly-accurate wearable device for Modus Health LLC of Boston, MA. Modus Health is a health technology company delivering

Ten steps to comply with FDA UDI requirements

The Sept. 24, 2016 Unique Device Identifier (UDI) compliance date for class II medical devices is quickly approaching. To assist device labelers through the UDI compliance process, Registrar Corp compiled a list of the top ten things to do to comply with the U.S. Food and Drug Administration’s (FDA) UDI requirements. 1. Determine the UDI

Are the BRIC markets still worth the effort?

Stewart Eisenhart / Senior Regulatory Analyst / Emergo Group If the title of this article sounds pessimistic, it’s for a reason. Compared to the highly evolved medical device markets in the U.S., Europe and Japan, the growing BRIC markets–Brazil, Russia, India and China–continue to perplex new entrants. The BRIC markets have long been pursued by device

GlobTek presents its latest level VI AC/DC adapter and connverter

T-43086-WWVV-X.X-Q Model is an addition to GlobTek’s Level VI compliant GT-43086 family and represents GlobTek’s 6 Watt wall plug-in series of AC/DC adapters (power supplies and chargers) with International Interchangeable blades. GlobTek’s changeable input blade system with individual field replaceable input plugs, including: North America and Japan NEMA 1-15P, Australian, UK BS 1363, European CEE

310 Watt desktop medical power supply meets efficiency level VI requirements

Power Partners releases a new 310 Watt medical grade desktop power supply from their PEAMD Series of AC and DC adapters. The 310 Watt unit is packed for ideal performance inside a compact case measuring 7.8 x 4 x 2 in. with a weight of only 3 lbs. The PEAMD310 Series is approved to the latest