Design Development and Certification of Medical Devices

Design Development and Certification of Medical Devices
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.



 

Understand the underlying principles behind the design and development of medical devices through an appreciation of:

  • 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

Please note that travel and accommodation is not included.

This course is now a Credit Bearing Short Course. This means that you can choose to complete the coursework and register onto the TOPRA MSc programme in February 2018. Please contact Kay for more information.


CPD

This course offers 17 CPD hours for successful completion, to learn about why CPD is important visit the Lifelong Learning page.


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Course fee: £1700.00 plus  VAT 


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

All fees are shown in Pounds Sterling. Terms and conditions apply. Those working for regulatory or government agencies, academic institutions, charities, patient groups or in full time education may be eligible for a discount. To see if you are eligible, For a discount please email us for the code.

- Please note the number of discounted places may be limited.
- All fees are shown in Pounds Sterling and do not include VAT 
- Fee excludes accommodation and travel. The delegate ticket includes refreshments at coffee breaks and buffet lunches (if applicable)
When
26/07/2017 - 28/07/2017
Where
TOPRA Office 6th Floor 3 Harbour Exchange South Quay London E14 9GE UNITED KINGDOM
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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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