DUBLIN--(BUSINESS WIRE)--The "An Introduction to the Design and Development of Medical Devices" conference has been added to ResearchAndMarkets.com's offering.
A comprehensive introduction to the design and development of medical devices, including device constituent parts of combination products.
This course introduces those who are new to medical device design and development to the critical elements of the process. It aims to provide delegates with an introductory insight into the tools and techniques required to design and develop a medical device. The importance of safety and efficacy will be covered, as will risk management and documentation. As combination products are a huge market, the course will also address device constituent parts of combination products.
Attending this training will provide delegates with a comprehensive appraisal of the critical elements and processes, and provide an opportunity to discuss the complexities involved with an experienced industry expert.
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
Programme Day 1
Overview to 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 11.00 uRefreshments
- 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
- Intended use
- Project complexity
- Mandatory requirements
- Design and development tools
The design and development process (continued)
- Inspiration, innovation and determination
- Materials and biocompatibility
- DFx, Design for?
- Manufacturing - key considerations
Programme Day 2
- 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
Discussion session and Q & A
For more information about this conference visit https://www.researchandmarkets.com/r/xy8828