Program Overview

Introduction to Quality and Regulation for Health Technology Products

The Introduction to Quality and Regulation for Health Technology Products is a comprehensive online course offered by Tampere University. This course provides a thorough overview of the regulatory and quality requirements for health technology products throughout their lifecycle.

Course Details

• Extent: 5 ECTS
• Course Dates: The next implementation is planned for the academic year.
• Fees: The previous fee was 300 + VAT.
• Faculty: Faculty of Medicine and Health Technology
• Language of Instruction: English
• Study Fields:
  • Management, Administration and Economics
  • Technology and Natural Sciences
  • Health and Welfare
  • Data Processing and Information Technology
• Organising Unit: Tree Continuing Education
• Mode of Study: Online studies
• Study Level: Other studies

Course Content

This online course gives participants a comprehensive and up-to-date overview of global industry requirements, regulations, and practices for health technology products. It introduces different types of health technology products, regulatory frameworks, stages of the product lifecycle, and risk-based thinking. Key concepts and definitions in the field, versatile product testing, product safety verification, usability, and related standards are also covered, along with ethical issues and clinical evaluation.

Topics Covered

• Health technology industry and different kinds of health technology products and solutions
• Regulatory framework, main standards, and regulations in the 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 products, including why they are needed and how they can be used to improve product safety
• Market approvals and post-market activities

Teaching Method

The course is an online course that participants can complete at their own pace. It is open from October 1, 2024, to February 28, 2025, and participants must begin the course no later than early January to complete it comfortably. The course is divided into 6 themes, each including different materials such as videos, readings, and assignments. Participants can proceed to the next theme after completing the previous one. A written learning assignment is also part of the course, which can be applied to the participant's own organization. Although the course is largely conducted independently online, the teacher is available when needed and provides feedback on assignments during the course.

Target Group

This course is targeted at those working or willing to work in health technology companies in various roles, including R&D, quality and regulation, production, marketing, sales, and management. It also provides essential knowledge for health technology start-ups and anyone looking to update their knowledge about requirements, regulations, and practices related to health technology products. The course can be customized for a company or organization.