Medical Device Manufacturing: Regulatory Compliance Guide

Medical device manufacturing requires strict adherence to regulatory standards to ensure patient safety and product efficacy. Understanding these requirements is crucial for successful market entry.

FDA Regulations

The FDA classifies medical devices into three categories:

• Class I: Low risk devices with general controls
• Class II: Moderate risk requiring special controls
• Class III: High risk requiring premarket approval

ISO 13485 Quality Management

ISO 13485 specifies requirements for quality management systems:

• Risk management throughout product lifecycle
• Design controls and validation
• Supplier management and control
• Corrective and preventive actions

Manufacturing Requirements

Medical device manufacturing must meet stringent standards:

• Validated manufacturing processes
• Environmental controls (cleanroom requirements)
• Material traceability and biocompatibility
• Sterilization validation
• Packaging and labeling compliance

Documentation and Records

Comprehensive documentation is essential:

• Device Master Record (DMR)
• Device History Record (DHR)
• Quality system procedures
• Validation protocols and reports