Software in Metrology for the Digital Age: Addressing Compliance Challenges with MID, NAWID, and MDR
Year: 2025
Type: conference-paper
Abstract: In the digital era, software is integral to devices regulated by European directives like MID, NAWID, and MDR, ensuring accuracy, reliability, and safety. While metrology has been crucial, software now plays an equally significant role, enabling data processing, automation, and new functionalities. Emerging technologies like AI, IoT, or cloud computing introduce compliance challenges. This article analyzes and compares software requirements in MID, NAWID, and MDR, focusing on software lifecycle, regulatory gaps, and risk assessment.
Source: EPJ Web of Conferences
Authors: Martin Koval, Jiří Tesař, Martin Staněk, Jaroslav Foltýnek
Language: English
Topic: Healthcare Regulation
Subfield: Health Information Management
Field: Health Professions
Domain: Health Sciences
Open Access status: diamond
Funder: Ministerstvo Průmyslu a Obchodu
OpenAlex ID: W4409236555