Introduction to quality and regulation for health technology products

The course covers the following topics:

• Health technology industry and different kind of health technology products and solution
• Regulatory framework, main standards and regulations at least in EU and USA
• Health technology product lifecycle and most common stages of R&D and product maintenance
• Ethical issues
• Patient safety and risk management
• Preclinical testing, biological evaluation, and clinical evaluation
• Quality systems for medical and health technology product. Why it’s needed and how we can use it to improve the product safety?
• Market approvals and post-market activities

Teaching

The course is an online course that the participant can complete at their own pace. The course is open from October 3, 2022 to February 26, 2023. In order to complete the course comfortably, you must begin it no later than early January 2023.

The course is divided into 6 themes. Each theme includes different materials, such as videos, reading or listening, and assignments. The next theme can be reached after completing the previous one. The course also includes a written learning assignment that can be also applied to participants own organization.

Although the course is largely conducted independently online, the teacher is always available when needed. The teacher also gives feedback on the assignments during the course.

Teachers of the course are experts in the field from Tampere University. Additionally, professionals from health tech companies and organizations are involved.

Application for the training becomes binding after the last application date.

For cancellation made after the end of the application period, 50% of the participation fee will be charged.
If the cancellation takes place 1-14 days before the start of the training, the entire price of the training will be charged.

In the event of an obstacle, the place of training can be handed over to a colleague. In trainings with separate selection criteria, a place cannot be handed over to another.