Quality, Safety, Standards and Law in Medical EngineeringLaajuus (3 ECTS)

Objective

After completion of this course the student will have an understanding of quality, usability and safety requirements, standards, EU directives, national law and authority regulations of medical devices. The student will comprehend the principles of quality control, quality engineering, clinical validation and risk management of medical devices. The student will have a basic understanding of standardization processes and national and international standardization organizations. The student will be able to work according to standards, directives, law and official regulations.

Content

1. Fundamentals of qualification
2. Quality
3. Usability
4. Safety
5. Good Manufacturing Practice
6. National and international standardization
7. Standards
8. EU Directives
9. Law
10. Clinical validation
11. Authority supervision and guidance
12. Placing a new product in the market
13. Incident and failure reporting

Assessment criteria, satisfactory (1)

1. The student is able to understand the quality, usability and safety standards for medical devices.
2. The student is able to understand medical device authority regulations and fundamentals of EU directives and national laws.
3. The student is able to apply standards and regulations on a basic level.
4. The student is able to understand how manufacturing, trade and use of medical devices are supervised.
5. The student is able to cooperate with health care professionals, standardization organizations, supervising authorities and trading companies on a basic level.

Assessment criteria, good (3)

1. The student is able to understand medical device quality, usability and safety standards from the point of view of healthcare professionals.
2. The student is able to understand the medical device validation process.
3. The student is able to recognize typical risks of health care technology.
4. The student is able to analyze hazardous and high risk situations and react in an appropriate way.
5. The student knows how to contact the authorities in the case of hazardous situation or device damage.

Assessment criteria, excellent (5)

1. The student understands Good Manufacturing Practice procedures.
2. The student is able to apply standards and regulations on an advanced level.
3. The student is able to implement the steps to obtaining marketing clearance from the authorities.
4. The student is able to cooperate with validation and standardization organizations.
5. The student is able to make a safety and risk plan for a medical device.