CRED Understanding Digital Health and Electronic Products

CRED Understanding Digital Health and Electronic Products
Regulation of electrical, electronic and software medical devices.

When
: 22 October 2020 
Where: TOPRA, 3 Harbour Exchange, London, E14 9GE, United Kingdom
Time: 09:00 - 17:15 GMT

Course overview

This course covers regulatory requirements for electrical, electronic, and software devices including current guidance, interpretation, and application of regulations. The practical considerations of design, development, and placement on the market for devices will be discussed. In particular, the regulation and approval of software devices is particularly challenging with limited guidance available and continual advancement of technology. 

Challenges and issues concerning active devices and software devices will be explored to discuss and review solutions that are being applied by regulatory professionals. The linkage between the electrical and electronic devices and software devices will also be described, with further presentation on how other processes like risk management, usability, and product life cycle management are linking everything together. Review of key requirements will be made including comparing and contrasting electrical, electronic, and software devices between US, European Union, and other countries.

Benefits to delegates

  • Meet and learn from experts in the field
  • Learn by doing- participate in case studies and interactive sessions
  • Build a network to support the rest of your career
  • Understand all the regulations around electronic devices and software, as well as  the development process and controls 
CPD: This course provides 8 CPD hours upon successful completion

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

Programme

Download a copy of the programme here.

Presenters include

Richard Vincins, Oriel STAT A MATRIX 

Suitable for

  • Regulatory Affairs Professionals writing reports and dossier sections for these products 
  • Regulatory Affairs Professionals who wish to develop their knowledge of the regulation of electrical, electronic and software devices
  • Those from allied industries who wish to have a comprehensive understanding of the subject
  • Those whose companies are considering developing software that may be considered as a device. 

Pricing  


Simply log in or create an account and register below. 
Type Member Non-member 
Standard    £925+VAT  £1,095+VAT

Discounted places
A limited number of discounted places are available at the rates below.
Please email us at meetings@topra.org for a discount code before making your booking.

 
Those working for regulatory agencies, government agencies or academic institutions 
 £693.75+VAT
 £821.25+VAT
Those working for charities, patient groups or in full-time education
 £462.50+VAT  £547.50+VAT

*VAT, if applicable, is charged at the rate of 20%

Terms and conditions

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

Related courses

When
22/10/2020
Where
TOPRA 6th Floor, 3 Harbour Exchange South Quay London E14 9GE UNITED KINGDOM
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