Packaging Services
DaVinci Molding is expanding its contract packaging capabilities with a dedicated white room operation and under ISO 13485 a class 8 clean room designed to support both start-ups and established medical device manufacturers.
Sterile Barrier Tray Sealing
We specialize in semi-automated sterile barrier tray sealing using medical-grade heat sealing equipment—ideal for early-stage programs and low-volume production runs (fewer than 1,000 trays/month). Our deep expertise allows us to design and engineer complete tooling systems for thermoforming, lidding, and sealing to meet ISO quality requirements.
Validation & Compliance
DaVinci supports full IQ/OQ/PQ validation of packaging processes in accordance with ISO 13485. Our team includes Subject Matter Experts (SMEs) who ensure regulatory compliance with FDA and ISO standards.
Customized Solutions
Tailored Packaging: We develop custom packaging solutions to match specific device requirements—considering size, geometry, sterilization method, and material compatibility.
Cleanroom Environments: Packaging is performed in ISO Class 8 and ISO Class 7 cleanrooms to maintain sterility and prevent contamination.
Sterilization Management: We handle EO and Gamma sterilization services, including validation and documentation.
Labeling & Printing: We support compliant labeling and printing services to meet FDA and international standards.
Quality Assurance
Every step of the packaging process is subject to rigorous quality control, ensuring product integrity and regulatory compliance from prototype to production.
Comprehensive Services
Our offerings include automated pouching, inventory management, retain sample handling, and data collection. We also manage “ship-to-sterilize” logistics—coordinating Gamma sterilization and returning product ready for final distribution.