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

• 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/