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

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.