top of page
Downloads
QSIT
ISO 14971:2000 Generic Checklist
Implementation of risk management principles and activities within a Quality Management System
Sample Warning Letter Citations
FDA Software Submission Guidelines
General Principals of Software Validation
Full Audit Process For Part 11 Evaluation
Background Document on PLM, MES and ERP systems
Deciding When to Submit a 510(k) for a Change to an Existing Device
bottom of page