- 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 toISO 62366 and FDA guidance for Medical Devices.
- 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 guideline
WHO SHOULD ATTEND
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.
- 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
A biomedical engineer & 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.