March 21, 2023, Free Interactive Webinar
Go to Market- Regulatory Pitfalls to Avoid


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. 


  1. FAQ by medical device manufacturers
  2. Feedback and rejections from authorities (case studies)
  3. Documentation Pitfalls (case studies)
  4. Testing Strategy pitfalls (case studies)


  • QA / RA Managers and Professionals
  • V&V Engineers
  • R&D Staff
  • Product development & Design
  • Testing & Regulatory compliance.


Orly Shenkar

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.

** Israel Time Zone

16:00 to 17:00 IL

Feel free to contact us

Start Time

3:00 pm – CET
March 21, 2023

Finish Time

4:00 pm – CET
March 21, 2023


On-Line Meeting