Documentation Deconstructed: Understanding the Technical file May 22, 2019
Good documentation is about doing it once. We explore how to use the Design Controls to build a core Technical File, and to use it to create DHF, DMR, Design Dossier and regulatory filings such as 510(k) and PMA. We will also explore the impact of the MDR to your Technical File.
Presenters: Terrance Thiel and Grant Bennett