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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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:
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.