Fundamentals of Medical Device Design and Development

Agenda

Medical device products vary in their range of risk (high to low) and in their complexity, however it is crucial they are designed with patient safety and efficacy in mind. With the advancement in technology in our ever changing world this drives device creativity and then onto the conversion of that idea into reality through the innovation journey, it is critical to factor in the device regulations when designing a device.

This training course will provide you with an overview of medical device design and development. You will be introduced to the key steps in the design process such as tools and techniques, intended use and materials and biocompatibility. You will appreciate the importance of safety and efficacy during the design process. Once completed you will understand the basics of designing and developing a device in accordance with the MDR, risk and quality management requirements.

Module 1  Overview of the regulatory requirements and routes to market

• Regulatory pathways
• Overview of the Medical Device Regulation (MDR)
• Device classification and the implications for your product

 Module 2 The design and development process

• The stages of design and development of medical device
• Examine key inputs to the process
• Design and development tools and techniques
• Materials and biocompatibility
• Manufacturability, cost, variability.
• Manufacturing – key considerations

Module 3  How to Control the design process

• Appropriate design and development planning
• Meaningful design outputs
• Design verification and validation
• Design reviews and transfer
• Change control
• Product Performance Spec

Module 4  Risk management and the design/development process

• Overview of the risk management requirements for a device
• Discover when risk management is applied – product plus process

Module 5 Clinical evaluation and product usability

• Planning your clinical evaluation
• User instructions

Learning Objectives

Delegates attending this   Fundamentals of Medical Device Design and Development Training Course will be able to:

• Gain a comprehensive overview of the design and development process
• Appreciate that a device is designed with the regulatory requirements and standards in mind to ensure safety and compliance
• Learn about design controls for you device
• Understand that selecting materials must comply with biocompatibility requirements to ensure compliance
• Access key information on documentation management and systems
• Understand how risk should be managed during the design and development
• Discover how development influences clinical evaluations, human factors and usability