“Loftware Spectrum® for Medical Device redefines how enterprises create, manage and print labels, enabling medical device enterprises to meet rigorous regulatory requirements.” Whether your company invests in a cloud or on-premise version, Spectrum for Medical Device provides “accuracy, consistency, and compliance.” When deciding whether Spectrum is the right solution for your medical device needs, here are […]
Managing the requirements and following the guidelines when it comes to regulatory compliance labeling can be a challenge. Especially for organizations in the chemical, medical, and food & beverage industries. It’s become a higher priority for companies with adherence to strict and evolving policies that have placed additional demands for compliance labeling. Chemicals: Global harmonized […]
Much like the experience we have all recently gained in the United States during the deployment of UDI for Class 3 and now Class 2 devices and soon Class 1. The goals of the European Medical Device Regulation (MDR) and In-Vitro Diagnostic Directive (IVDR) are to provide for the safety and well-being of the consumers […]
The European Commission legislation is introducing new compliance requirements on medical devices and creating completely new medical device regulations (MDR). Following in the footsteps of the Food and Drug administration of the US, EU has decided to adopt the Unique Device Identifier (UDI) for all medical devices and In Vitro Diagnostics (IVDR). This will be […]