Medical Device Design and Development (5 cr)

Evaluation scale

H-5

Content scheduling

1.Healthtech industry and legislation
Definitions of medical devices, MDR, IVDR, classification
Different actors in the field: Authorities, Notified Bodies, Economic Operators
Role of the PRRC (Person Responsible for Regulatory Compliance)
CE marking
EUDAMED database
2. Quality Management Systems
Quality system standards (ISO 9001, ISO 13485)
Process-based thinking
Documentation requirements
Risk management and usability engineering processes (ISO 14971, IEC 62366)
Change management
Product development process, Design Control procedures
3. Product Development
Requirements management
Software lifecycle (IEC 62304 + A1)
Use of standards to demonstrate compliance / harmonized standards (e.g., IEC 60601 series)
Traceability requirements
Technical documentation, Design History File
General safety and performance requirements
Verification and validation
Other applicable legislation

Objective

After completing the course the student:
- is familiar with legislation and regulatory bodies that play a key role in product development of medical devices
- is able to designate commonly used standards for product development in medical devices and understand their importance in product development
- understands the purpose and requirements for risk management process
- understands the purpose and impact of the quality management system for product development

Content

- Legislation and regulations on medical device product development
- Product development standards
- Risk management
- Quality system
- Software as a medical device

Materials

Materials provided by the teacher on the digital learning platform

Teaching methods

Lectures and group exercises conducted as in-person teaching
The course materials, individual assignments, study material for independent learning and interim exams are provided on the ItsLearning platform.

Exam schedules

After each module of the course, there is a exam related to that specific module, with a maximum score of 15 points. All exams must be passed. Each midterm can be retaken once during the course.
At the end of the course, it is possible to take a comprehensive exam covering all modules, if necessary.

Pedagogic approaches and sustainable development

The course introduces the product development of medical devices, with a particular focus on the related regulatory framework and industry-specific practices.
Through group work, students will practice working as part of a product development team and applying what they have learned in practical contexts.

The course materials are available in English. Lectures are mainly in Finnish, but the possibility to study the course in English is provided.

The course also explores themes of sustainable development from the perspective of the medical device lifecycle.

Student workload

The course is worth 5 ECTS credits, which corresponds to an estimated workload of 135 hours.
The workload is divided as follows:

9 hours (12 × 45 min) of in-person lectures
27 hours (12 × 3 × 45 min) of group-based project work conducted in classroom sessions
99 hours of independent study, group work and assignments, following the instructions and materials provided on the ItsLearning platform

Evaluation methods and criteria

At the end of each topic area, there is an exam, each worth a maximum of 15 points. The group assignment is also worth up to 15 points, making the maximum total score for the course 60 points. A minimum of 40% of the total score, i.e., 24 points, is required to pass the course. The final grade is based on the total number of points earned.

In addition, there are mandatory assignments on the digital platform, which are graded on a pass/fail basis.
Each exam, the group assignment, and the mandatory digital platform tasks must be completed with a passing grade.

Lecture attendance affects the total score as follows:

0–20%: –8 points
20–30%: –4 points
30–50%: no effect
50–60%: +1 point
60–80%: +2 points
80–100%: +3 points

Failed (0)

Failing Criteria
The student's total score for the course is below 40% of the maximum score and/or mandatory assignments have not been completed.

Assessment criteria, satisfactory (1-2)

Basic Competence
The student is familiar with the definition of a medical device and is aware of the related legislation. They are able to seek additional information when needed and can operate in the professional environment according to given instructions.

Assessment criteria, good (3-4)

Good Competence
The student is able to work independently in a professional environment and understands the rationale behind industry practices. They comprehend legal interpretations and can act accordingly. They are capable of producing documentation to support the conformity assessment of a medical device based on their own expertise.

Assessment criteria, excellent (5)

Excellent Competence
The student can independently interpret legislation related to medical devices and is able to create practical procedures to ensure compliance. They can critically assess industry discussions and understand the application of legislation from the perspectives of different stakeholders, companies, and products. They are capable of evaluating the technical documentation of a medical device in terms of regulatory compliance and are familiar with the related registration process.

Further information

The digital learning platform is used for course communication.