Medical Device Design Control | Oriel STAT A MATRIX

Medical Device Design Control 101

A primer on how to properly document your design and development process, track subsequent changes, and understand what’s required by law.

Covered in this paper:

  • The what, why, and how of design controls

  • The meaning of design inputs, outputs, verification, and validation

  • The difference between a Design History File (DHF), Device Master Record (DMR), and Device History Record (DHR)?