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Introduction to Document Control in Medical Device Development


Who needs to read this guide

Medical device developers using paper-based systems (or managing documents with Google Docs and DocuSign) can easily 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.

Why managing projects with Google Drive, DropBox and email could be costing you money and risking failed audits

What digital document controls you need for ISO 13485 and FDA compliance.

How you can take control of your entire document lifecycle with Lean document management tools

How Document Control Software can be right-sized to your needs

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