RDEC offers specialized packaging design services for medical devices and consumables, ensuring safety, compliance, and efficiency throughout the product lifecycle. From concept to commercialization, our solutions address all levels of packaging needs and regulatory requirements.
- Primary, Secondary, and Tertiary Packaging Design: Creating effective packaging solutions for medical devices and consumables, tailored to protect products from inception through commercialization.
- Labeling Design: Developing compliant labeling solutions in accordance with 21 CFR Part 801 to meet regulatory requirements and enhance usability.
- Packaging Material Evaluation: Assessing materials to ensure compatibility with sterilization processes and maintaining product integrity.
- Shipping Qualification Studies: Drafting and supporting shipping qualification studies in alignment with ASTM D4169 standards to ensure safe product transportation.
- Packaging Verification and Validation Support: Providing thorough support for packaging testing, verification, and validation to meet performance and regulatory standards.