Medical Devices Road to Market, e-course

About the course

Get a solid intro to the key steps in bringing a medical device to market. This course covers the essentials of the development process, with interactive elements and knowledge checks to boost your learning. The course is given in English.

Who will benefit from this course?

• Aspiring Medical Device Developers: Individuals aiming to enter the medical device field and learn the development process.
• Regulatory Affairs Professionals: Those needing knowledge of medical device regulations and market entry (including PRRC).
• Product Managers and Engineers: Professionals driving the development of medical devices from initial concept to market launch, ensuring adherence to regulatory standards throughout the process.
• Healthcare Innovators: Entrepreneurs bringing new medical technologies to market.
• Quality Assurance Specialists: Individuals ensuring the safety and efficacy of medical devices during development and post-market.

Key takeaways from the course

The training goal is to gain a basic understanding and overview of the medical device development process, including the essential steps and considerations for bringing a medical device from concept to market.

Upon completion of the course, the participant shall:

• Have a general understanding of the key concepts and definitions related to medical devices.
• Be aware of the CE marking process and its role in market access.
• Recognize the basic challenges and complexities of entering the medical device market.
• Understand the initial steps involved in moving from an idea to a marketable product.
• Be familiar with the primary responsibilities of manufacturers and other key stakeholders.
• Gain a basic awareness of regulatory considerations and strategies.
• Understand the importance of risk management at a foundational level.
• Have a general overview of clinical evaluations, investigations, and post-market activities.
• Recognize the importance of proper documentation in the development process.

Here´s what you´ll learn

1. Introduction to Medical Devices and CE Marking

• Introduction to Medical Devices
• Introduction to CE-Marking
• Navigating Market Complexity
• Idea to Market

2. Considerations for Medical Device Development

• Define Your Device: Qualification and Classification
• Manufacturers Responsibilities and Key Operators
• Regulatory Strategy

3. Medical Device Development and Market Entry

• Introduction to Key Processes
• Risk Management
• Design and Development
• Clinical Evaluation and Clinical Investigations
• Production and Manufacturing
• Post-Market Surveillance and Post-Market Clinical Follow-up

4. Documentation

5. Final Steps for CE-Marking and Market Launch