QUALITY MANAGEMENT FOR DEVELOPMENT OF MEDICAL DEVICE SOFTWARE
Juolahti, Johannes (2020-08-20)
QUALITY MANAGEMENT FOR DEVELOPMENT OF MEDICAL DEVICE SOFTWARE
Juolahti, Johannes
(20.08.2020)
Lataukset:
Julkaisu on tekijänoikeussäännösten alainen. Teosta voi lukea ja tulostaa henkilökohtaista käyttöä varten. Käyttö kaupallisiin tarkoituksiin on kielletty.
suljettu
Julkaisun pysyvä osoite on:
https://urn.fi/URN:NBN:fi-fe2020082563043
https://urn.fi/URN:NBN:fi-fe2020082563043
Tiivistelmä
This master’s thesis’ purpose is to study the role of a quality management system in agile software development in the field of medical device software (MDS). More specifically, this thesis will focus on the intersection of general software development quality assurance and different regulations concerning medical devices and the effect that they pose on the requirements for the quality assurance (QA) for a business operating in this field.