An Introduction to the Design and Development of Medical Devices Training Course (ONLINE EVENT: December 10-11, 2024)

This intensive two-day course will introduce those who are new to medical device design and development to the critical elements of the process. It has been designed to provide delegates with an insight into the tools and techniques required to design and develop a medical device and offer an essential overview of the current regulatory landscape. The importance of safety and efficacy will be covered, as will risk management and documentation. As combination products are a huge market, the programme will also address device constituent parts of combination products.

Attending this event will provide delegates with a comprehensive appraisal of key aspects of this process and an opportunity to discuss the complexities involved with an experienced industry expert.

Benefits of attending:

• Gain a comprehensive overview of the design and development process
• Comply with the regulatory requirements and standards
• Learn about design controls
• Review materials and biocompatibility
• Access key information on documentation management and systems
• Understand how risk should be managed
• Consider human factors and usability studies

Certifications:

• CPD: 12 hours for your records
• Certificate of completion

View the course: https://bit.ly/3XkZC31

Agenda

Day 1

Overview of the regulations and market routes

• Regulatory pathways
• Medical Device Directive (MDD) vs Medical Device Regulation (MDR) - key differences
• EU vs US (FDA) - markets to consider
• Medical device vs combination product (drug/device and device/drug) - which regulation applies?
• Device classification and the implications for your product
• Resources and sources

The design and development process

• The stages of design and development
• Key considerations
• Terminology
• Intended use
• Project complexity
• Mandatory requirements
• Design and development tools
• Inspiration, innovation and determination
• Materials and biocompatibility
• DFx, Design for…………?
• Manufacturing - key considerations

Day 2

Design control

• Appropriate design and development planning
• Translation of marketing requirements
• SMART design inputs
• Is a trace matrix appropriate?
• Meaningful design outputs
• Verification and validation
• Design reviews
• Design transfer
• Design history file vs technical file
• Change control
• Notified Bodies (NB)

Risk management - what is required?

• What is risk management and when should it be applied?
• What does the guidance say?
• Help or hindrance?
• How to implement a practical risk management plan
• Tools and techniques to help you succeed

Clinical evaluation, human factors and usability - how to comply

• Planning your clinical evaluation
• How to incorporate human factors and usability studies into your design and development process - MDR and FDA requirements
• User instructions
• Training considerations - when and who do you need to train?
• Formative studies
• Validation/summative studies

Who Should Attend

• Design and development personnel
• Development engineers
• Quality personnel
• Regulatory personnel
• Design control professionals
• Documentation managers
• Programme managers
• Anyone who needs an overview of the medical device design and development process