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.


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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.