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Fundamentals of Medical Device Design and Development

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Course Overview

 

Medical device products vary in their complexity, however it is crucial they are designed with patient safety and efficacy in mind. As advances in technology drives device innovation, 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.

 

With the Educo Post Learning Implementation Plan (PLIP) you will have the framework to apply and implement the knowledge acquired in the training, supporting you in your development. Learn more about how we deliver live online training.

Key Learning Objectives

  • 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
Post Learning Implementation Plan (PLIP)

Pre-course

  • Access to the Educo Training Portal
  • Submit your needs analysis and objectives for training by completing a simple online form

Action Plan

  • At the end of the training you will create an action plan to help you implement and develop your new skills and knowledge

Reinforcement Session

  • Delivered 3 to 4 weeks after the training
  • It is a 1 hour virtual session enabling the group to reinforce the key learnings from the training and cover and subsequent questions and challenges
Module 1

Overview of the regulatory requirements and routes to market

  • Regulatory pathways
  • Overview of the Medical Device Regulation (MDR)
  • 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

 

Module 2

The design and development process

  • The stages of design and development of medical device
  • Examine key considerations
  • Review terminology
  • What is the intended use of the device?
  • Project complexity
  • What are the mandatory requirements
  • Design and development tools and techniques
  • Inspiration, innovation and determination
  • Materials and biocompatibility
  • Design for X
    • Manufacturability, cost, variability.
  • Manufacturing – key considerations
Module 3

Examining design control

  • Appropriate design and development planning
  • Translation of marketing requirements
  • Is a traceability matrix required for your device?
  • Meaningful design outputs
  • Design verification and validation
    • What and why?
  • Design reviews and transfer
  • Design history file vs technical file
  • Examining the change control
    • What is it?
    • Managing it
  • Notified Bodies (NB)

 

Module 4

Risk management and the design/development process

  • Overview of the risk management requirements for a device
  • Discover when risk management is applied
  • What does the guidance say?
  • Help or hindrance?
  • How to implement a practical risk management plan
  • Tools and techniques to help you succeed

 

 

Module 5

Clinical evaluation, human factors and usability

  • Planning your clinical evaluation
  • Learn 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

 

 

 

TBC

This course is designed for anyone working in medical device design and development. It is also applicable for those working in areas impacted by design and development such as regulatory affairs, clinical and risk. These include: Design and Development Professionals | Quality | Regulatory Affairs | Documentation Professionals.

Could your team benefit from this course?

We can customise this course to meet the requirements of your organisation, delivered as a classroom and/or online course.

For more information you can email us at [email protected] or call +44 (0) 203 111 7357.

Or please summarise your objectives by completing the form below.

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• The training course is delivered either online or in a classroom. Please check which course format you have booked.
• For live online courses, dates and times of modules are subject to change
• Please contact us for the module dates of future deliveries.
• For live online courses, module durations are approximate.
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