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8 reviews for
Medical Device Design and Development for New and Legacy Products
23 February 2026 | 5-Day Live Online Course
Original price was: £1,395.£995Current price is: £995.
The price is for all 7 Modules |Â Register for Module 1-Free
Identify and compile the critical documentation for your new or legacy device to ensure complianceÂ
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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.
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.
Who Should Attend?
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
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
23, 24, 25, 26 & 27 February 2026 | 21, 22, 23, 24 & 25 September 2026
Module 1
FREE to Attend | Live & Recorded
Sign up
21 January 2026 | 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
Session 1
23 February 2026 | 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
Session 2
24 February 2026 | 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
Session 3
25 February 2026 | 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
Session 4
26 February 2026 | 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
Session 5
27 February 2026 | 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.
Format, Dates & Times
Find out when this course is running so you can plan your training. Scroll down to view the full agenda.
23, 24, 25, 26 & 27 February 2026
5-Day Live Online Training
Register at the top of the page. The largest price saving of £400 will be applied.
21, 22, 23, 24 & 25 September 2026
5-Day Live Online Training
Register at the top of the page. The largest price saving of £400 will be applied.
On-Demand Access
Can’t wait for the next course date?
Get instant access to the training materials by selecting ‘On-Demand’ from the drop-down menu above. Start learning at your convenience. You’ll also be added to the next live session, giving you the opportunity to attend and interact directly with the trainer if you wish.
Course Times
For live online delivery, each sessions start time and duration can be found under the agenda tab. All times given are UK time.
Group Discount
If you want to train a small group, we offer a group discount between 5% and 50% depending on the course and number of attendees.
For a quote, complete our contact form by following the link. Get in touch.
Customised Team Training
We also design and deliver fully customised team training focused on your products, processes, technologies and challenges. This is ideal for specific training requirements or larger groups. Please get in touch with us for more information.
For more information, complete our contact form by following the link. Get in touch.
What is Included?
Certification
Download your official Educo Life Sciences Certificate of Attendance to showcase your achievement and professional development.
Reinforcement Session
Attend a live reinforcement session around four to five weeks after the course to refresh key topics and ask new questions.
Access to Recordings for 5 Weeks
Enjoy unlimited access to all session recordings for up to five weeks after the final session — perfect for revision or catching up.
Learner Reference Guide
Attendees receive an overview packed with key concepts, examples, and references from your training to support you long after the course concludes.
On-Demand or Live Online
This course is delivered live or you can access on-demand materials immediately to begin learning straight away.
12 Hours of Learning
This course includes a total of 12 hours of learning plus the reinforcement session.
Expert Trainer
Engage directly with leading trainers who bring real-world experience and insider knowledge to every session.
Register For Module 1 | Free
There are limited spaces on 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.
Additional Course Information
Free Online Module
Free Online Module
- Some of our courses include a free to attend module 1. Please check above to see if this applies to this course.
- If applicable, module 1 is free to attend and delivered online at a date 3 to 8 weeks before the full course start date.
- To register for module 1, please submit your details in the form located above.
- Module 1 is recorded so if you are unable to attend, you can catch up ahead of the course start date.
Full Course Information and Pricing
Full Course Information and Pricing
- To attend the full course, you must register online at the top of the page by selecting the course dates from the drop-down and clicking enrol to add the course to your basket. Once added, please follow the checkout instructions to pay via credit card or bank transfer.
- There are price tiers for this course. The dates of these are located above. The earlier you register the more you save.
- The full training course is delivered either online or in a classroom. Please check which course format you have booked.
- For hybrid training – In the event we do not have enough people on one of the options we will contact you to discuss switching.
- For live online courses – The dates and times of modules/sessions are subject to change.
- For live online courses – The module/session durations are approximate.
On-Demand Information and Pricing
On-Demand Information
- Most courses are available on-demand. If you select this option you will be able to begin training instantly.
- You will gain access to a previous live online session, slides and learner reference guide.
- You will also be added to the next live session, giving you the opportunity to attend and interact directly with the trainer if you wish.
- Depending on the course length you will have access to the on-demand materials for 1 to 3 months.
8 reviews for Medical Device Design and Development for New and Legacy Products
23 February 2026 | 5-Day Live Online Course
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Original price was: £1,395.£995Current price is: £995.Labelling and UDI for Medical Devices and IVDs
23 March 2026 | 4-Day Live Online Course
Educo Life Sciences –
This is a new course – Reviews will be added after the first delivery!
OxSonics Therapeutics –
This 5days (2hours per day) course was very helpful to learn the good practice; of design and development of medical devices. I did learn quite a lot during that course and have filled some gap in my knowledge around the medical device design and manufacturing regulation aspect.
EMMES BIOPHARMA GLOBAL s.r.o. (verified owner) –
Great course with lots of useful topics. A lot of information was given during the course. I liked the fact that we could ask different questions and the lecturer answered everything, even if the questions were lengthy.
EG Technology Ltd –
The course was beneficial
Vectura –
N/A
Biosensors Europe SA (verified owner) –
Great course, very useful to get a global understanding on Design and Development with a lot of specific examples. Also great to have Richard with such a huge knowledge and experience on all different MD fields.
Biosensors Europe SA (verified owner) –
Great course, very useful to get a global understanding on Design and Development with a lot of specific examples. Also great to have Richard with such a huge knowledge and experience on all different MD fields.
Mouthuy Group, NDORMS, University of Oxford –
The Design and Development course I attended offered significant insights into the regulatory landscape surrounding medical devices. The course content was highly comprehensive, and the experienced trainer provided valuable instruction, drawing on many personal examples from his own career in Regulatory Affairs. This practical approach made the training engaging and directly relevant to real-world applications. The course was particularly helpful in clarifying the complexities of regulatory documentation, which I had previously found ambiguous. It has greatly improved my understanding of what needs to be included in regulatory submissions, helping me navigate the critical components of regulatory compliance with much greater confidence.