Contact Us

Design Control Process Automation

Software to Automate Design Control Processes Including the Management of Design History Files (DHF) and Other Critical Documents Throughout the Entire Product Development Process

Per 21 CFR Part 820, "Each manufacturer of any class III or class II device shall establish?and maintain the procedures to control the design of the device in order to ensure that specified design requirements are met." Compliance with this regulation is documented in the Design History File (DHF) and results in the creation and management of many documents specific to the development history of the medical device.


Watch Related Videos

Download Free Resources
White Paper: Automating Electronic Engineering Change
White Paper: Change Control - Continuous Quality Improvement in FDA and ISO Environments
White Paper: Engineering and Quality Teams in Medical Device Firms: Can We All Get Along?
White Paper: How to Address the Top 6 Pains in DHF Management
White Paper: Managing Change Control to Comply with FDA and EU Regulations
White Paper: Reducing the Documentation Burden in FDA Design Control
Q&A: Compliance with 21 CFR 820 and ISO 13485 Using MasterControl
Product Data Sheet: MasterControl Change Control™
Demo Video: MasterControl Quality Management System (QMS) Overview

Design Control Process Automation for GxP Process

MasterControl automates medical device GxP processes to improve efficiency and speed time to market. Processes include:

  • Design Control
  • Corporate and Supplier Compliance
  • Production / Manufacturing Support
  • Labeling and Promotion

What Solutions Are You Looking For?

Roll over the list of solution categories below to view the related MasterControl product, then click to go to that solution's product page.

Bill of Material Management
Design Control Automation
Document Control
Change Control
Corrective/Preventive Action
Training Management
Quality Audits
Customer Complaints
Medical Device Reporting
Supplier Management