Design Development and Certification of Medical Devices

Design Development and Certification of Medical Devices
This Masterclass will help you to gain an understanding of the design, manufacturing and quality management requirements for product development, the importance and concepts of risk management and the ways in which risk is managed from the design stage onwards, so that you can provide appropriate advice on the key regulatory issues affecting design, certification and manufacturing of medical devices.




When: 8-10 September 2025
Where: TOPRA Office, 3rd Floor City Reach, 5-6 Greenwich View Place, London, E14 7NN
Day 1 start time: 14:00 GMT | Day 3 end time: 16:30 GMT

This course is also available to attend online.

Suitable for

This course is essential for:

  • Delegates from the medical device industry who wish to develop their knowledge of the design development and certification of medical devices;
  • Delegates from allied industries who wish to have a comprehensive understanding of the subject;
  • Students on the TOPRA MSc programme.

Note: this course is also Module 14 of the MSc Regulatory Affairs.

Course information

This Masterclass will cover:

  • Design / development planning, functionality and prototyping
  • Risk Assessment
  • Statistical approaches to design
  • Material choices and biological safety assessment
  • The importance of ISO standards in device development
  • Testing and validation
  • Inputs and outputs
  • Rapid prototyping
  • Assessing usability and performance
  • The role of statistics in the design development tool kit
  • Certification: Developing documentation to support regulatory assessment of a new device
  • Specialised processes, including sterilisation
  • Packaging design
  • Software as a medical device
  • Post-marketing design and development activities
  • Global standards, regulatory requirements and the links with the technical documentation page.

Benefits for delegates

This course will enable you to:

  • Be able to critically evaluate the design of a device including the materials it is made of
  • Demonstrate a critical understanding of the safety and performance of devices using applicable product standards for the EU and other global markets
  • Critically evaluate the principles and practice of risk management as set out in ISO 14971 to a level where it can be applied to a complex medical device
  • Be able to create and appraise the documents required to apply for certification of medical devices for the EU and other global markets
  • Give appropriate advice to the medical device team on key regulatory issues affecting the design, development and manufacturing of devices
  • Produce the necessary technical documentation within project timeframes
  • Critically appraise and evaluate communications from competent authorities, notified bodies and research publications covering the design, development and certification of medical devices globally
CPD: This course provides 19 CPD hours upon successful completion.

To learn more about why Continuing Professional Development is important, visit our Lifelong Learning page.

Programme

You can view and download the draft programme here.

Module Leaders

        


Helen Erwood PhD CBiol MTOPRA, Director Global Regulatory Affairs, ESPL Regulatory Consulting

 
         

Jason Collins, Managing Director, ESPL Regulatory Consulting

Presenters

Presenters for this training course include:

  • Monir El Azzozi, CEO, Easy Medical Device
  • Jonathan Bradshaw, Head of Development and Systems Engineering, OOONO Medical A/S
  • Chris Collins, ESPL Regulatory
  • Stuart Freeman, Toxicology Consultant, Farino Consulting
  • Denise Lee, Vice President Clinical Operations, Heidelberg Pharma AG
  • Kevin Madden, Head of Professional Development, Medical Devices and Artificial Intelligence, BSI
  • Greg Thay, Managing Director & Human Factors Consultant, Thay Medical 

Pricing


 Standard training course registration fees
 Event Registration Type Price (GBP)
 Standard Price 
 TOPRA Member		 £1,900.00 + VAT*
 Standard Price
 Non-member		 £2,375.00 + VAT* 
 TOPRA MSc Students
  		 £1,650.00 + VAT*

Save on the full cost of membership and £180 on the price of your training
course when you add TOPRA membership to your booking (membership fees are exempt from VAT).
*VAT, where applicable, is charged at the rate of 20%.
 
 Discounted training course registration fees
 Event Registration Type Price (GBP)
 Government or academic rates
 TOPRA Member
 £1,425.00 + VAT*
 Government or academic rates 
 Non-member
 £1,781.25 + VAT*
 Charities, patient groups, full-time education rates
 TOPRA Member		 £950.00 + VAT*
  Charities, patient groups, full-time education rates
  Non-member
  £1,187.50 + VAT*

Places are also available for those in low-income countries as defined by the World Bank.
*VAT, where applicable, is charged at the rate of 20%.
 

Please email meetings@topra.org for a discount code before making your booking.

Terms and conditions

By booking a place on this course you are agreeing to the training terms and conditions.

 
When
08/09/2025 - 10/09/2025
Where
TOPRA Office 3rd Floor City Reach 5-6 Greenwich View Place London E14 9NN UNITED KINGDOM
Sign in or create an account to register Last day to register is 07/09/2025
My registration status: Not registered
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NOTE
Important instructions before booking - If your company name or VAT number does not appear here or you would like to be invoiced using a different VAT number, please email finance@topra.org

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