An Introduction to the Design & Development of Medical Devices: 2-Day Programme | London, United Kingdom; May 27th-28th, 2020

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Nov 28, 2019, 05:15 ET

DUBLIN, Nov. 28, 2019 /PRNewswire/ -- 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

Agenda

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
Terminology
Intended use
Project complexity
Mandatory requirements
Design and development tools

Workshop one

The design and development process (continued)

Inspiration, innovation and determination
Materials and biocompatibility
DFx, Design for?
Manufacturing - key considerations

Programme 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

Workshop two

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/p8joh4

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