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
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.
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
Please fill in participants details, Only payment will ensure participation & training certificate.
- 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.
- Bank transfer:
Top Li-Med Technology Bank: Hapoalim Branch: 537 Account No. 187391
Please send a reference of the transfer by email to firstname.lastname@example.org
***Invoice will be issued and emailed separately***