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Medical Device Design Control  Compliance Services
 (21CFR820.30 cGMP)  Quality System Regulation

Medical Device Design Control Services

Toltec's design control services help companies comply with the design control requirements of FDA's CFR 820.30 and ISO13485:2003.  

Gap Analysis.  Let a Toltec Specialist provide a Gap Analysis on your Design Control System.  For a fixed price we will:

Review procedures for compliance to FDA 820.30 and current industry practices 
Review your Design History File(s) on selected projects
Develop a summary report of findings, severity and priority of findings, as well as recommendations

Other Services. We offer hands-on document development for the following aspects of medical device design control:

Project and V&V plans
Creation of Design Input and Design Output documents

Requirements specifications
Design descriptions

Medical Device Design Control Services Design Validation and Verification, including Software, including test protocols, test execution, and test records
Risk Analysis, FMEA Analysis, FTA Analysis
Requirements Traceability 
Design Review records
Design Control System and Procedure Development

Design Control Relation to FDA Submissions:

  • Medical devices are subject to various regulations in terms of submission and approval (FDA)
  • Design control deliverables are needed for the submission packages in many cases

Related links:

FDA's Design Control Guidance: http://www.fda.gov/cdrh/comp/designgd.html

Global Harmonization Task Force: http://www.ghtf.org/

Copyright 2006 Toltec International, Inc. All rights reserved.

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