Overview

1. Do your engineers avoid documentation? 2. Are you in an FDA-auditable environment where traceability and precise validation/quality documentation is critical to assuring the best care for your patients? 3. Is your team blessed with myriad new projects and time-to-market deadlines, but struggling to find an engineer capable of rigorous, understands-the-entire-system level of expertise for the development of use cases, requirements, test cases, FAT/SAT, I/O/PQ in Jama, ValGenesis, or even MS Word? Supplement your staff with a 15-year systems integration veteran who loves to develop expert-level documentation for medical device and aerospace applications and who has lead validation teams through $15M+ worth of medical device manufacturing systems. I’m Alex Stoermer, and developing articulate, “best we’ve ever read” documentation for systems integration projects and custom manufacturing equipment is my engineering passion.