Tag: Medical Device Document Control Software Systems

Sep 02
Linking SOPs, DHFs, and Risk Files Within a Single Document Control Framework

The Strategic Role of Medical Device Document Control Software Systems In highly regulated industries, particularly life sciences and medical device manufacturing, documentation is at the center of compliance, quality, and safety. Standard Operating Procedures (SOPs), Design History Files (DHFs), and risk management files serve as foundational records for regulatory submissions, audits, and continuous improvement initiatives. […]