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

Medical Device Design Control Services

Design control compliance services are intended to help companies comply with the design control requirements of the FDA (CFR 820.30), ISO 9001:1994/ISO13485, and ISO 9001:2000. The following are services we provide:

Design Control System and Procedure Development
Quality Planning for Development Project
Design Documentation Compliant with Design Control

Specification development
Design descriptions
Specification update
Design Reviews
Medical Device Design Control Services Design Validation and Verification, including Software
Risk Analysis, FMEA Analysis, FTA Analysis
Requirements Traceability and Configuration Management
Process Validation
Training
Documentation Development for Existing Medical Devices
Assistance in device classification
Determination of Class I, Class II, Class III, or Combination thereof
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/


 
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