Introduction to quality and regulation for medical product development

The course covers the following topics:

• Product life cycle and most common phases of R&D project from research to the product launch
• Regulatory framework for health tech products, main standards and regulations in EU and USA and the main parts of the most common quality systems for the medical products 
• Quality systems for medical and health technology product development. Why it’s needed and how we can use it to improve the product safety?
• Medical and health technology products. Definitions, packaging, sterilization, registrations and regulatory.
• Most typical tests for electrical and biological safety as well as mechanical and biomechanical testing

Teaching

The course includes lectures, visitor case presentations and/or interviews, joint discussions and small group works. The course also includes a written learning assignment that can be applied to participants own organization. There is small exam at the end of the course.

The teacher of the course is Eija Pirhonen.
She has worked with biodegradable materials, medical devices and quality systems in several companies. The focus areas have been in materials research, product development, regulatory compliance, quality, IPR and clinical trials.

In addition, professionals from health tech companies and organizations are involved.