FDA-REGULATED MEDICAL DEVICE DOCUMENTATION, Terumo BCT

THE CHALLENGE
Terumo BCT manufactures blood component and cellular technology systems regulated by the FDA. Documentation for these systems must serve multiple audiences—clinical operators, biomedical technicians, and regulatory auditors—while maintaining strict compliance with FDA 21 CFR Part 820 quality system regulations. TerumoBCT acquired Harvest, which had inconsistent and inaccessible documentation.

The Harvest BMAC system and related blood and adipose centrifugal devices required comprehensive documentation that would:
• Guide clinical operators through complex procedures with zero tolerance for error
• Support biomedical technicians performing maintenance and troubleshooting
• Satisfy FDA regulatory requirements for device labeling and instructions for use
• Maintain clear traceability for quality management system audits

MY APPROACH
I developed multi-layered documentation suited to the high-stakes healthcare environment:

Regulatory Compliance:
• Ensured all documentation met FDA requirements for medical device labeling
• Followed ISO 13485 quality management system guidelines
• Maintained document control procedures including version tracking, change history, and approval workflows
• Coordinated with Quality Assurance, Legal, and Regulatory Affairs teams for documentation review and approval

Audience-Specific Content Development:
• Created operator manuals with step-by-step clinical procedures, warnings, and precautions
• Developed service manuals for biomedical technicians with troubleshooting flowcharts and maintenance schedules
• Wrote quick reference guides for point-of-care use in clinical settings
• Produced training materials supporting clinical education programs

Risk Mitigation:
• Collaborated with clinical affairs and risk management teams to identify potential use errors
• Implemented clear hierarchical warning systems (DANGER, WARNING, CAUTION) throughout documentation
• Used structured authoring tools (Arbortext) to ensure consistency and completeness
• Tested procedures through user validation studies to identify documentation gaps

OUTCOMES
• Successfully supported FDA submissions and regulatory audits with zero documentation-related findings
• Documentation approved by clinical users for clarity and usability in real-world healthcare settings
• Contributed to quality system that maintained ISO 13485 certification
• Reduced operator error incidents through improved warning placement and procedure clarity

SKILLS DEMONSTRATED
• FDA-regulated medical device documentation
• Multi-audience technical communication
• Risk-based documentation approach
• Quality management system compliance (ISO 13485, 21 CFR Part 820)
• Structured authoring and document control
• High-stakes accuracy and precision writing