The Universal Device Identification (UDI) system was developed by the U.S, Food and Drug Administration (FDA) as global UDI compliance to protect patients and clinicians by improving traceability of medical devices through a common and shared system. It has and continues to fulfill its role in safety and traceability tenfold and medical device software has […]
We have shared about innovative electrical products in the transportation sector. Still, the aerospace industry is also advancing through the first hydrogen-powered Vertical Take-Off and Landing (VTOL) aircraft which will fly over 1,150 miles. Sirius Aviation AG stated, “The Sirius Jet is a high-performance, zero-emission VTOL aircraft propelled by hydrogen-electric propulsion system.” This newfound […]
May 26, 2022, marked the deadline for medical device manufacturers to comply with the EU MDR requirements. The main objective of this compliance mechanism was to “establish a robust, transparent, predictable and sustainable regulatory framework for medical devices…which ensures a high level of safety and health whilst supporting innovation.” While the MDR has been in […]
A doctor in Raleigh, North Carolina was indicted for the extreme misuse of a medical device in addition to Medicare fraud and making and using materially false Healthcare Documents. Many of the patients were misled by thinking the medical device, was sterile and was used for the first time during their surgery. A balloon […]
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 […]