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Please let me know if you know of any central or commercial IRB/IECs in India or Africa.  I am looking to set up a series of digital health type studies and would like to use one IRB. ------------------------------ Peggy McLaughlin United States ------------------------------

I would be interested in speaking with anyone who has recent experience conducting medical device clinical studies in Poland. Peggy McLaughlinMPMAdvisors@gmail.com Cell +1 650 504-8501

Michele I have used Avania Clinical (formerly Five Corners) for several studies.  You should inquire with them (and any others) and inquire in regards to their experience in the clinical area for your product. ------------------------------ Peggy McLaughlin United States --------------------- ...

You can ask a legal firm - Hogan Lovells or King and Spaulding come to mind - who have offices in DC to delivery it for you. ------------------------------ Peggy McLaughlin United States ------------------------------

I wanted to bring the following proposed rule to folks' attention. www.federalregister.gov/documents/2018/09/13/2018-19865/medical-device-submissions-amending-premarket-regulations-that-require-multiple-copies-and-specify Published in September, Marjorie Schulman noted today on the Special 510(k) Pilot ...