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Module 1 Registration
1 review for
Medical Device Design and Development for New and Legacy Products
15 April 2024 | 1 Week Live Online Course
£895.00
The price is for all 7 Modules | Register for Module 1-Free
Identify and compile the critical documentation for your new or legacy device to ensure compliance
Course Overview
When designing and developing a new medical device, quality and patient safety must be at the forefront of all processes, inputs, studies and more. For companies with legacy products under the old MDD, article 10 of the Medical Device Regulation (MDR) requires the design of all products which can be a challenge.
For professionals working on new-to-market devices, this training course will provide you with the step-by-step process to create the technical documentation ready for approval in the EU/US. You will be introduced to the design process, design control, risk management and validation.
For professionals working on legacy products, this course will teach you best practices for transitioning your documents from the MDD to the MDR. You learn tools and techniques such as conducting a gap analysis, identifying what is missing and putting in place a strategy to be fully MDR compliant.
This course will be tailored depending on whether you are developing a new product or transitioning legacy products. Once registered, you will be asked which area is of focus and certain modules (modules 3 and 4) will be adapted to ensure you get the most from the course.
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 module 1 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
- Learn how a new device is designed and developed from beginning to end
- Appreciate a device is designed with the regulatory requirements and standards in mind to ensure safety and compliance
- Develop a strategy to efficiently transition legacy products from MDD to MDR
- Learn about design controls for your device
- 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, manufacturing, human factors and usability
- Examine the design and development process for Software as a Medical Device (SaMD) and electronics.
Learn more about the course by toggling through the tabs below (trainer, agenda, who should attend?)
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
13 March 2024 | 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
15 April 2024 | 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
16 April 2024 | 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
17 April 2024 | 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
18 April 2024 | 120 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
Module 6
18 April 2024 | 90 mins | 3:00 PM UK
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
19 April 2024 | 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.
This course is designed for professionals working on a new medical device who want to ensure they are designing and developing in accordance with the requirements. It is also suitable for professionals working on transition documentation from MDD to MDR who want some support and guidance. Typical roles include:
- Regulatory affairs
- Persons Responsible for Regulatory Compliance (PRRC)
- Clinical
- Risk management
- Quality
- Engineers
- Manufacturing Operations
- 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.
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. |
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1 review for Medical Device Design and Development for New and Legacy Products
15 April 2024 | 1 Week Live Online Course
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