Development of a Hand Held Thromboelastograph
Abstract
The project objective is to develop a hand-held, ultra-portable thromboelastograph, ready for submission for FDA 510(k) clearance for clinical assessment of platelet function. Entegrion has designated the device as the Portable Coagulation Monitor (PCM). This is a three year project, and this report summarizes progress to date at the end of year two (Y2). The overall summary of the Project Timeline is: 1- V 2.0 Prototype Design, Testing, Validation months 1-12 2- Formal definition of Design Requirements & Specification Months 13-15 3- Product Design & Development Months 16-24 4- Certification Testing and subsystem design corrections if needed months 25-30 5- Manufacturing Documentation Months 30-36 6- FDA 510(k) Clearance Months 30-36, concurrent with #5 above.
Document Details
- Document Type
- Technical Report
- Publication Date
- Jan 01, 2013
- Accession Number
- ADA578641
Entities
People
- Arthur Bode
- Taegen Sullivan