Medical Device Design and Development for New and Legacy Products

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The price is for all 5 Modules Register for Module 1-Free

Identify and compile the critical documentation for your new or legacy device to ensure compliance 

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Enrol before | 2 February to save £400 | 23 February to save £200

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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.

What is Included in a Live Online Course?


  • Direct access to an expert trainer
  • Interactive and engaging sessions with exercises and discussions
  • Bitesize learning
  • Access to the Educo Life Sciences Training Portal
  • Unlimited access to the recordings for 4 to 5 weeks after the last session
  • Reinforcement session delivered 4 to 5 weeks after the course (online) providing you with extra time with the trainer
  • A validated certificate of attendance is available for you to download
Register For Free Online Session


There are limited spaces for the introductory session. If demand is high you may not be able to attend the live session, however you will be sent the recording. Priority is given to full registrations.

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

Learn more about the course by toggling through the tabs below (trainer, agenda, who should attend?)

Post Learning Implementation Plan (PLIP)


  • 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


Richard Young has over 25 years’ experience in the medical device and IVD industry with products such as class 3 implants to electromedical infusion systems. Richard has extensive experience in regulatory affairs, GMP (quality), GLP (laboratory testing) and clinical affairs. Richard has held various positions within industry such as QA/RA Manager and Director, Quality Assurance and Regulatory Compliance at various companies including Biomet, Plasma Surgical and Zimmer Limited.


Richard has been an independent consultant for over 6 years, supporting companies with regulatory and quality advice on a range of different products. He has extensive experience of European regulations including the MDD, IVDD and more recently the MDR and IVDR. In addition, Richard understands the US FDA requirements for devices and diagnostics. He also has a comprehensive working knowledge of device ISO standards such as 13485 and 14971.

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.

Free First Module and Pricing
  • Module 1 is free to attend for this live online course and is delivered a few weeks before the start date.
  • To enrol on module 1, please submit your email at the top of the page.
  • All sessions are recorded. If you are unable to attend module 1, you can catch up ahead of the course start date.
  • There are price tiers for this course. The dates of these are located above the course overview.


Frequently asked questions (FAQs)

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.

Complete our contact form by following the link. Get in touch.


• 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.