Which Regulatory Requirements Must be Considered?

Regulatory requirements play a central role in MedTech automation. Key frameworks include:

• FDA regulations (e.g., 21 CFR Part 820 and 21 CFR Part 11)
• MDR (Medical Device Regulation in the EU)
• GMP (Good Manufacturing Practice)
• GAMP 5 (Good Automated Manufacturing Practice)
• ISO 13485 (Quality Management System for Medical Devices)

These regulations significantly influence system design, especially regarding:

• Documentation (e.g., audit trails and complete traceability)
• Software validation (including CSV – Computer System Validation)
• Process reliability
• Risk management