Design Control Templates

The Design Control Templates offering is a suite of documents that comprehensively establishes an all-inclusive Product Development Program (PDP).

The Design Control Templates document suite is comprised of a set of 25 interrelated standard operating procedures, templates, and forms ready for customization. The included forms are provided in Microsoft Word® and Microsoft Excel® formats. Other materials provided include a 20 page overview of design controls and a step-by-step guide for customizing and utilizing these procedures to implement a design control program.

Customer Videos

Deere - Hitachi (6:29)

How MasterControl Makes Your Job Easier (3:50)

Using MasterControl for FDA Compliance (3:53)

The documents contained in the Design Control Templates suite have been specifically created to meet the FDA design control regulations outlined in 21 CFR 820.30. This Medical Device Design Control program has been successfully customized and implemented by a variety of companies, both start-ups and larger organizations. The Design Control Templates offering is the most comprehensive set of off-the-shelf medical device design control documents currently on the market. Furthermore, it is ready to be uploaded into your MasterControl system to provide a fully automated design control program to help bring high quality medical products to market faster.

The Design Control Templates documentation set includes the following:

SOP: Product Development Program (Top Level SOP that establishes the overall product development process and the application of design controls.)
SOP: Product Development Program - Glossary of Terms
SOP: Phase 0 - Feasibility
SOP: Phase 1 - Design Requirements and Planning
SOP: Phase 2 - Design Development
SOP: Phase 3 - Design Verification
SOP: Phase 4 - Design Transfer
SOP: Phase 5 - Design Validation
SOP: Prototype Management
SOP: Lab Notebook Maintenance
SOP: Design Risk Analysis for Medical Devices
SOP: Verification and Validation Protocol Development and Maintenance
SOP: Design History Files
SOP: Design Review
Template: Design FMEA
Template: Design Review Meeting Minutes
Template: Design Requirements and Traceability Matrix
Template: Feasibility Summary and Project Charter
Template: Design Transfer Plan
Form: Engineering Work Order
Form: Engineering Work Order Log
Form: Laboratory Notebook Traceability Log
Form: Action Item Tracking Log
Form: Commercial Release Checklist
Form: Design Review

Free Downloads Related to Design Control Templates
	Product Data Sheet: Design Control Templates
	Product Data Sheet: MasterControl MD™
	White Paper: Reducing the Documentation Burden in FDA Design Control