Introduction to quality and regulation for health technology products

When working with medical devices or other health technology products, it is important to know how this industry operates and what regulations and standards must be followed to get your product on the market.

This online course gives you a comprehensive and up-to-date overview of global industry requirements, regulations, and practices. It introduces different types of health technology products, regulatory framework, stages of product lifecycle, and risk-based thinking. The key concepts and definitions in the field, versatile product testing, product safety verification, usability and related standards will be also introduced not forgetting the ethical issues and clinical evaluation.

The course covers the following topics:

• Health technology industry and different kind of health technology products and solution
• Regulatory framework, main standards and regulations in EU and USA
• Health technology product lifecycle and most common stages of R&D and product maintenance
• Ethical and sustainability 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 1, 2024 to February 28, 2025. In order to complete the course comfortably, you must begin it no later than early January.

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.

Target group

This course is targeted for those who are working or willing to work in health technology companies in different roles in R&D, quality and regulation, production, marketing and sales and management. The course gives essential knowledge also for health technology start-ups and anyone who wants to update his or her knowledge about requirements, regulations and practices related to health technology products.

The course can also be customized for a company or organization.

“This is an excellent opportunity for companies to support the development of expertise among their staff,” says Saara Hassinen, CEO of Healthtech Finland.