Introduction to Document Control for Medical Device Developers

Medical device developers using paper-based systems (or managing documents with Google Docs and DocuSign) can  fail to meet the demands of ISO 13485 and FDA 21 cfr Part 11.

To keep med dev projects on track and meet the regulation, you need complete control over the way documents are handled, from requirements gathering to design validation and FDA inspection.

This guide explains the difference between document management and document control - and why it matters in medical device development.