Quality system - ISO 13485 (Medical Devices - Quality Management System): ​

• Process evaluation and adaptation

• Facilities review

• Development and review of standard operating procedures (SOPs)

Risk management 

• Risk management plan - ISO 14971 (Medical devices. Risk analysis)​

• Risk management report

Post-market surveillance: ​

• Post-marketing surveillance plan (PMS)

• Periodic Safety Update Reports (PSUR, PMSR)

Customised training

Audit support