Regulation and Standards of Well-Being TechnologyLaajuus (5 cr)

Objective

After completing the module, studentrecognises the relevant factors in nursing and patient securityrecognises central bodies of standardization and regulationknows the relevant standards and legislation concerning medical equipment and Well-Being Technology operational environmentknows how to take in consideration regulatory requirements in developing products and services, requirement validation testingis able to plan and participate in auditing regulatory requirementsunderstands the significance and implementation methods of defining and managing requirementsis able to organize requirement engineering based to the needs of stakeholders and clients.

Content

Central sectionsStandardization bodies: ISO, IEC, FDA, among othersCentral standards in Well-Being Technology fieldAuditing processrequirement engineeringrequirement validation, testing process