Design Control Templates and Toolkit

The MasterControl Design Control Toolkit is your ultimate guide to an all-inclusive Product Development Program (PDP). The design control templates offered in the toolkit are the most comprehensive set of off-the-shelf medical device design control document suites currently on the market.

The Design Control Toolkit offers 21 interrelated design control templates, standard operating procedures and forms ready for customization. The included document forms are provided in Microsoft Word® and Microsoft Excel® formats. Other materials provided include a step-by-step guide for customizing and utilizing these procedures and 8 hours of Quality Compliance Consulting (QCC) to help you implement your design control.

Product Data Sheet

Design Control Toolkit

Product Videos

Hundreds of companies around the world use MasterControl to automate core business processes and document management activities to promote collaboration, improve decision making, and accelerate time to market.

Play

MasterControl QCC Design Control Template Toolkit

Play

Quality by Design (QbD) - Part 1

Play

Demo Introduction: MasterControl Quality Management System

Free Resources

Select all the resources you’re interested in downloading

White Paper: Change Control - Continuous Quality Improvements in FDA and ISO Environments White Paper: Engineering and Quality Teams in Medical Device Firms: Can We All Get Along? White Paper: Managing Change Control to Comply with FDA and EU Regulations White Paper: Reducing the Documentation Burden in FDA Design Control White Paper: How to Address the Top 6 Pains in DHF Management
Product Data Sheet: MasterControl Change Control™

MasterControl Design Control Toolkit Contents

The design control templates contained in the Design Control Toolkit have been specifically created to meet the FDA design control regulations outlined in 21 CFR 820.30. It has been successfully customized and implemented by a variety of device companies, both start-ups and larger organizations. Furthermore, it is ready to be uploaded into the MasterControl quality management software (QMS) suite to provide a fully automated design control program, which will help you bring high-quality medical products to market faster.

The Design Control Toolkit includes the following:

SOP: Product Development Plan SOP-0001
SOP: Design Control SOP-0002
SOP: Change Control SOP-0003
SOP: Risk Management SOP-0004
SOP: Design Review SOP-0005
SOP: Verification and Validation SOP-0006
SOP: DHF SOP-0007
SOP: DMR SOP-0008
FORM: Change Control FRM-0003
FORM: Phase I Design Review FRM-0005A
FORM: Phase II Design Review FRM-0005B
FORM: Phase III Design Review FRM-0005C
FORM: Phase IV Design Review FRM-0005D
FORM: Phase V Design Review FRM-0005E
FORM: Risk Assessment FRM-0004
FORM: Traceability Matrix FRM-0002
FORM: DFMEA
TEMPLATE: Project Charter
TEMPLATE: Risk Management Plan
TEMPLATE: Design Transfer PLN-0001
TEMPLATE: Project Design Plan

Learn More About How to Benefit from Your Design Control Toolkit

To learn more about MasterControl’s Design Control Toolkit, or to discuss how the kit’s design control templates can assist your organization’s quality management, contact a MasterControl representative.

The QMS Provider for the FDA

MasterControl Inc. and its partner, i4DM, are expanding their FDA project, serving as the QMS providers for a second FDA division. The two companies have been the QMS providers for the FDA's Office of Regulatory Affairs since 2009. Now they will also serve as quality providers for the Division of Pharmaceutical Analysis, which is part of the FDA's Center for Drug Evaluation and Research.

Learn More