Meet ISO13485:2016 requirements for medical device quality management

• Clause 4.2.5 – UDI record collection
• Clause 5.5 – Administrator and user roles and responsibilities
• Clause 7.5.1 – Establish and maintain records for each or batch of distributed medical devices
• Clause 7.5.6 – System validation
• Clause 7.5.8 – Medical device identification
• Clause 7.5.9 – Record traceability

Exclusive questionnaire helps user to follow UDI coding policy for medical device

• Easy to manage product packaging types and levels
• Quick to manage product types, series and models

Capable of searching products via relevant keywords

Support diverse methods to integrate with your production line

Usage-based billing allows flexible budgeting