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

FREE to Attend | Live & Recorded

Sign up

15 January 2025 | 60 mins | 1:00 PM UK

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

Register For Module 1 | Free

There are limited spaces for module 1. 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.

Module 2

10 February 2025 | 150 mins | 1:00 PM UK

The design and development process

• The stages of design and development of medical device
• Examine key considerations
• What is the intended use of the device?
• Review terminology
• Project complexity
• What are the mandatory requirements
• Standards
• Design and development tools and techniques
• Inspiration, innovation and determination
• Materials selection and biocompatibility considerations
• Manufacturing – key considerations

Module 3

11 February 2025 | 120 mins | 1:00 PM UK

Examining design control

Module 3 is divided into two modules depending on your specific focus. 3A is aimed at professionals with an interest in new product development. 3B is aimed at those working on legacy products.

3A: Examining design control for new product development

• 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

3B: Examining design control for legacy products

• Appropriate design and development planning and Article 10 of the MDR
• Historical requirements where did the product come from?
• Meaningful design specifications
  • Acceptance criteria
  • Risk management
  • standards
• Existing design verification and validation
  • GAP assessment?
• Design reviews and transfer as a mechanism of DHF acceptance.
• Examining the change control
  • Control going forwards
  • What is it?
  • Managing it

Module 4

12 February 2025 | 120 mins | 1:00 PM UK

Clinical evaluation, human factors and usability

Module 4 is divided into two modules depending on your specific focus. 4A is aimed at professionals with an interest in new product development. 4B is aimed at those working on legacy products.

4A: Clinical evaluation, human factors and usability for new product development

• Planning your clinical evaluation
• Learn how to incorporate human factors and usability studies into your design and development process
• User instructions
• Training considerations – when and who do you need to train?
• Formative studies
• Validation/summative studies

4B: Clinical evaluation, human factors and usability for legacy products

• The product is already designed, how do I document these areas
• User instructions
• Historical performance?
• User Interface of Unknown Provenance
• Confirmatory Summative studies
• Validation/summative studies

Module 5 & 6

13 February 2025 | 210 mins | 1:00 PM UK

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

Design and process validation

• Biocompatibility
  • Biological |Risk Assessment
  • extractables and leachables
  • material selection again
• Sterilisation
  • Method selection
  • Validation
  • Shelf life and transit testing
  • environmental process controls
  • routine controls

Consideration of these factors in ongoing change management

Module 7

14 February 2025 | 120 mins | 1:00 PM UK

Review of software & electronics

• Criticality of process in the design of these product types.
• ISO 62304.the standard
• FDA guidance on software
• IEC 60601 and UL2601, welcome to the hardware side of the equation!
• Criticality of usability in these product types as they have user interfaces.

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.

Richard has extensive experience in assisting clients with technical file documentation to support their product development, ensuring compliance with CE marking or FDA approval. He has also been providing guidance to clients who are transitioning from legacy MDD CE marked products to the new MDR, which involves additional documentation, studies, and data. With his training expertise, Richard is capable of improving the skills of professionals in device design and development.