Design Control & Documentation

Design Control

The FDA [21 CFR 820.30] and ISO 13485 mandate design control. When set up early and used correctly it saves time and money. Give us a call to find out how.

  • Customized systems for this FDA- and EU–mandated activity
  • Integrated with project management
  • Integrated with document control
  • Traceability for product decisions and rationales
  • System management
  • Training


Documentation is the lifeblood of any biotechnology company. Early implementation of document control speeds product development and agency clearance to market.

  • Customized document systems integrated with project management and design control
  • We write/review documents for:
    • Research and Development
      • SOP
      • Experiment protocols
      • Spreadsheets for data capture and analysis
      • Product design specifications
      • Design verification protocols and reports
      • Reports to support product claims to regulatory agencies
      • Traceability Matrices, Technical Files, Design Dossiers, Manuscripts
    • Clinical Trials
      • Protocol design, case report forms, informed consent
      • Data analyses
      • Clinical reports
      • Investigator Brochures
    • Manufacturing
      • Bills of Materials
      • Raw material, component, in-process and final test specifications
      • Equipment validation protocols and reports
      • Process design, verification, and validation protocols and reports
      • Production SOP, data capture
      • Material Safety Data Sheets [MSDS]
    • Quality Assurance
      • Development of customized Quality System Manual
      • Customized scalable Quality System Procedures
      • Risk assessments/hazard analyses
      • Test methods, data capture
      • Test method validation reports
      • Design and Device History Files
      • Device Master Records
      • Traceability Matrices
      • Product Certificates of Analysis
    • Marketing
      • Customer requirements
      • System specifications
      • Design validation protocols and reports
      • Product labeling
      • Website content
      • Technical Support notes