Is your regulatory strategy in place, do you have a clear road map? Have you talked to the authorities prior to submission? Have you documented your R&D activities? Have you justified your choice of testing or standards? Are you aware of regulatory changes that might affect your product or your market? Also, after market approval? Then this is the webinar for you!
Please note: Link will be send to registered email prior to the webinar.
Orly has a BSc and MSc degree in Biotechnology Engineering and has extensive experience in Quality and Regulation of Medical Devices with global companies. She builds, manages and implements Quality Management Systems throughout the entire product life cycle as well as Technical files/Design dossiers. Orly helps medical device manufacturers implement their Quality System across all departments, from design and development through production and post-market approvals. Orly’s specialty includes supporting medical device start-ups in various fields, including: Active, Active Implantable, Software Devices and Cardio vascular devices.