ISO 13485 Certification

ISO 13485 is the quality management standard for medical device manufacturers. It ensures consistent design, development, production, and delivery of medical devices that are safe for their intended purpose.

• Required for medical device manufacturing
• Mandatory in many countries for market access
• Ensures patient safety and device efficacy
• FDA recognition for US market
• CE marking requirement for Europe

• Risk management throughout product lifecycle
• Design controls and validation
• Sterile manufacturing controls (if applicable)
• Traceability and recall procedures
• Clinical evaluation processes
• Post-market surveillance
• Regulatory compliance documentation