Research and Development of Medical EquipmentLaajuus (5 cr)

Objective

After completing the module, student
- recognises the relevant factors in nursing and patient security
- recognises central bodies of standardization and regulation
- knows the relevant standards and legislation concerning medical equipment and Health Technology operational environment
- knows how to take in consideration regulatory requirements in developing products and services, requirement validation testing
- is able to plan and participate in auditing regulatory requirements
- understands the significance and implementation methods of defining and managing requirements
- is able to organize requirement engineering based to the needs of stakeholders and clients.

Content

Central sections
- Standardization bodies: ISO, IEC, FDA, among others
- Central standards in Well-Being Technology field
- Auditing process
- requirement engineering
- requirement validation, testing process