Browsing by Author "Kiviniemi, Kari"
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Elektroniikan, tietoliikenteen ja automaation tiedekunta | Bachelor's thesis(2009) Kiviniemi, Kari - Quality, usability and agility of medical device development
School of Electrical Engineering | Master's thesis(2010) Kiviniemi, KariThe recently amended Medical Device Directive imposes new requirements for medical device development and manufacturing. The most important new requirements are usability engineering' process and software classification as a medical device. New requirements were set to ensure the safe use of the device. Conformity is shown by more comprehensive documentation. The purpose of this thesis is to improve the quality of product development process. Agile methods were brought into the product development process of a mid-sized production company. The usability engineering process is introduced and different software development methods are inspected, but their actual implementation is ruled out. Using agile methods in product development shortens the project pass through time and improves quality. Especially SCRUM methods are inspected and were applied into the production company's R&D project management. The new methods improve the company's documentation procedures and project management. Documentation is improved by instructions and templates and the usage of company's information systems is enhanced.