Medical Device Development CharacteristicsLaajuus (5 ECTS)

Objective

After completing the course, the student knows medical device regulation and selected standards, understands methods for requirement specification and risk assessment, and applies knowledge to practical development task related medical device development including regulative issues.

Content

• European Medical Regulation and FDA Standards
• Quality Systems and Standards
• Control and Audit Practices
• Formal Documentation
• Requirement Specification and Risk Assessment

Assessment criteria, satisfactory (1)

Student has some knowledge about medical device regulation and selected standards, partly understands specification and risk assessment methods, and utilizes learned knowledge and skills to medical device development including regulative issues.

Assessment criteria, good (3)

Student knows medical device regulation and selected standards, understands specification and risk assessment methods, analyses learned knowledge, utilizes references, and applies knowledge and skills to solve a challenging problem for medical device development including regulative issues.

Assessment criteria, excellent (5)

Student masters medical device regulation and selected standards, has high-level understanding of requirement specification and risk assessment methods, analyses learned knowledge critically, utilizes high quality references in advanced manner, and applies knowledge and skills to solve a challenging problem or producing a new solution for medical device development including regulative issues in advanced manner.