Preparation of 510Ks, pre-IDEs, IDEs, and PMAs
Answering regulatory questions
Reviewing and editing 510Ks
Design and preparation of packaging, labels, product inserts and instructions for use
Blackwell Device Consulting
P.O. Box 718
Gresham, Oregon 97030-0172
US Tel +1 704-498-4058
UK Tel +44 20 32864188
Download Angela Blackwell's CV.
Download Gerald Blackwell's resume.
Update 7 March 2023: Premarket Approval
Calcivis Imaging System
Copyright © 2023 Angela and Gerald Blackwell