Design Development and Certification of Medical Devices

Design Development and Certification of Medical Devices
This Masterclass (also module 14 of the MSc Regulatory Affairs) 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.

 20-22 November 2023
Where: TOPRA Office, London, UK 
Start Day 1: 13:00  End Day 3: 16:30

Also available as an online  course, please  click HERE to register

Course overview

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.


Will be available close to the event date.

Module Leader

Helen ErwoodHelen Erwood, PhD, CBiol., MRSB., MTOPRA, MIoD
ESPL Regulatory, UK

Helen has been working in Regulatory Affairs for over 30 years and set up her own consultancy company in 2000. Prior to that Helen gained a broad experience in various sectors in Regulatory Affairs, initially for nearly 10 years with ICI Pharmaceuticals (now AstraZeneca) where she worked in anti-infectives, antiseptics and new pulmonary drug developments, and was eventually responsible for initiating the Company’s Regulatory Compliance function. From there Helen moved to Fisons in 1993 where she led a Regulatory Compliance team through some of the aftermath of the FDA debacle in the early 1990s, becoming Associate Director of Compliance and Regulatory Affairs following the takeover of the company by RPR. In 1996 she moved to the Regulatory Affairs function of SmithKline Beecham Consumer Healthcare, where she was Category Director for the global oral health and gastrointestinal product portfolios, directing activities in support of this $1 billion portfolio, from where in 2000 she resigned to work independently within the industry.

Helen is a board-level director of three consultancy companies; in the UK, Ireland and Switzerland. Within ESPL she leads an enthusiastic team of regulatory affairs professionals and IT / publishing specialists.

Helen’s experience covers a wide range of different regulatory and compliance areas, including product developments in NCEs, the consumer sector, cosmetics, devices and borderline drug / device, cosmetic / device combinations and radiopharmaceuticals. Helen’s current portfolio of interests is very varied, covering many of the sectors above. In addition to providing regulatory consultancy services for specific projects and submissions, she enjoys teaching and lectures regularly both in-house and externally on drug and device CTD/CMC requirements, EU and US procedures, regulatory strategy, QP training and voluntary support for some of the training programmes for TOPRA.

Helen lists her most useful assets as her continuing curiosity and enthusiasm for regulatory matters and her infectious sense of humour.


TOPRA Masterclasses are developed and delivered by a faculty  of expert speakers from relevant industry, agencies, notified bodies and other stakeholders and are validated by the University of Hertfordshire.

Suitable for

  • Students of the TOPRA MSc programme
  • 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


Course fees:
Type Student Delegate
Standard    £1500 + VAT £1700 + VAT 

Discounted places
A limited number of discounted places are available  for those working for regulatory or government agencies, academic institutions, charities, patient groups or full time education at £1275+VAT 
Please email us at for a discount code before making your booking.
Please note that discounted places are not valid for those enrolled on the MSc course and cannot be used in conjunction with any other offer
  • VAT, if applicable, is charged at 20% 
  • The registration fee does not include accommodation 
  • Refreshments and lunch are included in the registration fee

Related Courses

Module 15: Clinical Evaluation of Medical Devices

Terms and conditions

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

20/11/2023 - 22/11/2023
TOPRA Office 6th Floor 3 Harbour Exchange South Quay London E14 9GE UNITED KINGDOM
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