Specializing in:

Preparation of 510Ks, pre-IDEs, IDEs, and PMAs

Answering regulatory questions

Reviewing and editing 510Ks

Document redaction

Design and preparation of packaging, labels, product inserts and instructions for use

Blackwell Device Consulting
P.O. Box 718
Gresham, Oregon 97030-0172
USA

US Tel +1 704-498-4058
UK Tel +44 20 32864188
Mobile 704-450-9934

Download Angela Blackwell's CV.

Download Gerald Blackwell's resume.

Update 7 March 2023: Premarket Approval
for the
Calcivis Imaging System

^{Copyright © 2023 Angela and Gerald Blackwell}