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[Emergo, UL] Some Assembly Required: Unique Considerations for Applying Human Factors to a Medical Products System

Regardless of a medical product’s complexity, manufacturers have many considerations when it comes to applying human factors during development. Applying human factors to a whole system of medical products versus a singular product might seem even more intimidating. Furthermore, additional complexities might emerge when applying human factors to a system of products where all products or compone..

Description The Commission and Member States have created MDR and IVDR tables. These tables aim to help manufacturers of medical devices and in vitro diagnostic medical devices, particularly small and medium-sized ones, understand the language requirements for the information and instructions that accompany a device in a specific country. The tables provide an overview of the language requiremen..

Procedures for the updates of the European Medical Device Nomenclature The European Medical Device Nomenclature (EMDN), as established by Article 26 of Regulation (EU) 2017/745 – Medical Device Regulation (MDR) and Article 23 of Regulation (EU) 2017/746 - In Vitro Diagnostic medical devices Regulation (IVDR), will be annually reviewed and updated based on the practical use of the EMDN and feedba..