Essays about: "ISO 14971"

Found 1 essay containing the words ISO 14971.

  1. 1. A Case Study on Tailoring SafeScrum to a Medical Device Software Organization

    University essay from Göteborgs universitet/Institutionen för data- och informationsteknik

    Author : Kosara Golemshinska; Rashad Kamsheh; [2019-11-18]
    Keywords : SafeScrum; Agile; Safety-Critical Medical Device Software; IEC 62304; ISO 14971; ISO 13485;

    Abstract : As a type of safety-critical systems, medical devicesneed to undergo a certification process to ensure their safety,which entails a significant amount of documentation. This approachis in stark contrast with the focus on shorter time-tomarketand flexibility to change that agile strives to achieve. READ MORE