Medical Device Manufacturing

Key Characteristics

• Volume: 1K–100K units/year (medium-low)
• Customization: High — patient-specific growing
• Tolerance: Microns for implants, sterility critical
• Compliance: 21 CFR 820, ISO 13485, DHR requirements
• Environment: Cleanroom (ISO Class 5-8)
• Worker Skill: Inspection to Craft — high documentation burden
• Key pain: Paper DHRs, multi-signature approvals, traceability