UDI

Unique Device Identification – UDI WHAT IS IT? The FDA’s Unique Device Identification (UDI) of medical devices aims to offer a practical solution to display standard product information in a standard format for a product’s distribution and use. This information needs to include a UDI in human and machine-readable form and includes (but is not […]

GS1

Global Standard 1 (GS1) GS1 US, a member of GS1®, is a non-profit information standards organization that brings industry communities together to solve supply-chain problems through the adoption and implementation of GS1 Standards. Manufacturers looking for guidance on labeling using Global Trade Item Numbers, or GTIN, go to GS1 to learn more about ways to […]

GHS & CLP

GHS: Hazard Communication Labelling The development of a harmonized hazard communication system, including labeling, safety data sheets, and easily understandable symbols is one of the major objectives of the Globally Harmonized System (GHS). To that end, the GHS includes appropriate labeling tools to convey information about each hazard class and category. Using symbols, signal words, […]

FDA – CFR Part 11 Title 21

The FDA’s Code of Federal Regulation(CFR) 21 Part 11 allows Medical Device and Life Science organizations to use electronic records and signatures in place of paper. The regulation applies to all aspects of the research, clinical study, maintenance, manufacturing, and distribution of medical products, and covers: Required records that are maintained in electronic format in […]

Compliance

Many organizations today struggle to manage their compliance requirements across multiple regulations, standards, and frameworks whether it is UDI, the MDR standards, GHS or other compliance initiatives. We understand your business is complicated and that you are often required to implement a labeling system as mandated by your customers or a regulatory agency. As part of our […]