Usability -No more the abandoned field:

Compliance to ISO 62366 standard & FDA guidance for Medical Devices.

September 24th, 2019

Leonardo City Tower Hotel, Tel-Aviv

Key Note Speaker: Alice Ravizza

 

COURSE MAIN TOPICS

  • The impact of regulatory requirements in design and post-market phases of medical devices;
  • Usability and usability engineering process in human errors prevention;
  • Risks identifications, assessment and management in medical devices use
  • Medical devices design, development, testing, compliance reporting, certification and marketing according to ISO 62366 and FDA guidance for Medical Devices.

WHAT YOU WILL LEARN

  • Design thinking methods for human-product interfaces of medical devices ensuring safety, efficacy, efficiency and user satisfaction in the intended use;
  • Methods of analysis and identification of risks and hazardous situations related to human errors in medical devices use;
  • Methods of risks management;
  • Tests strategies for medical devices usability;
  • Guidelines for drawing up a validation report on the usability of a medical device according to ISO 62366 and FDA guidelines

PARTICIPANT PROFILE

Any of the following profiles having general knowledge of European medical standards and guidelines: Clinical and biomedical engineers, Manufacturers of medical devices, Medical devices designers, Regulatory Affairs specialist of medical devices companies; Responsible for the Quality System in medical devices companies.

SPEAKER PROFILE

Alice Ravizza
Alice Ravizza

Alice Ravizza, biomedical engineer, is adjunct professor at Politecnico di Torino, Italy for the course “Medical device regulations”.

She manages the start-up company USE-ME-D srl at I3P-Politecnico di Torino that is focused on prevention of human errors in medicine through medical device design and validation. Author of multiple publications regarding regulatory compliance and usability of medical device.




SCHEDULE
09:00 - 09:30     Registration
09:30 – 11:00    The impact of regulatory requirements in design and post-market phases of 
                          medical devices
11:00 - 11:30     Coffee break
11:30 – 13:00  Usability and usability engineering process in human errors prevention
13:00 - 14:00     lunch Brake
14:00 - 15:00     Risks identifications, assessment and management in medical devices use
15:00 – 15:15    Coffee break
15:15 - 16:30    Medical devices design, development, testing, compliance reporting, certification 
                          and marketing according to ISO 62366 and FDA guidelines
16:30 - 17:30     F2F meetings

REGISTRATION

Registration form:

Please fill in participants details, Only payment will ensure participation & training certificate. 

Registration fee:

  • Special fee for June: 790 NIS
  • Early bird registration fee: 1,390 NIS
  • Full registration fee: 1,590 NIS

The registration fee includes:

  • Conference documentation, lunch & refreshment.
  • The registration fee is payable in advance.
  • A certificate of attendance for professional development will be given to each participant who completes the workshop.

Terms of payment

  • Bank transfer:
Top Li-Med Technology
Bank: Hapoalim
Branch: 537
Account No. 187391

Please send a reference of the transfer by email to office@edu-med.info
***Invoice will be issued and emailed separately***