Medical Device Cases: ISO 13485 Compliance Guide for Custom Packaging
Introduction
– Importance of proper medical device packaging
– Regulatory requirements overview
– Why ISO 13485 compliance matters
– GADAO’s expertise in medical cases
What is ISO 13485?
– Definition and overview
– Why it’s important for medical devices
– Key requirements
– Benefits of compliance
– Global recognition
Medical Device Packaging Requirements
– Sterility maintenance
– Protection from contamination
– Cushioning and protection
– Labeling requirements
– Documentation requirements
EVA Foam for Medical Device Cases
– Why EVA is ideal for medical applications
– Biocompatibility
– Sterilization compatibility
– Durability and reliability
– Cost-effectiveness
Custom EVA Cases for Medical Devices
– Design considerations
– Size and shape customization
– Internal compartment design
– Handle and closure options
– Printing and branding
ISO 13485 Compliance in Manufacturing
– Quality management systems
– Documentation and traceability
– Testing and validation
– Supplier management
– Continuous improvement
Common Medical Device Case Applications
– Diagnostic equipment cases
– Surgical instrument cases
– Portable medical device cases
– Laboratory equipment cases
– Pharmaceutical packaging
– Case studies with real examples
Choosing an ISO 13485 Compliant Manufacturer
– Certification verification
– Quality track record
– Technical expertise
– Customization capabilities
– Turnaround time
– Cost competitiveness
GADAO's Medical Device Case Solutions
– ISO 13485 certified
– 20+ years of experience
– Advanced manufacturing capabilities
– Quality assurance processes
– Competitive pricing
– Fast turnaround
Cost Considerations for Medical Device Cases
– Material costs
– Customization costs
– Certification costs
– Volume discounts
– ROI analysis
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