Packaging and labelling are essential for ensuring the safety, efficacy, and compliance of medical devices. At Qualentra Global, we provide packaging and labelling solutions that meet ISO 11607 and FDA standards, ensuring device protection and clear, compliant instructions for safe use.
- Regulatory Compliance with ISO 11607, FDA 21 CFR, and MDR
- Packaging Design & Material Selection
- Sterile Packaging Validation & Testing
- Labelling Design and Compliance (CE Marking, Symbols, Instructions for Use)
- Package Integrity and Performance Testing
- Global Market Labelling Adaptation
End-to-End Lifecycle – 6 Stages of Packaging & Labelling Services
Regulatory Requirements Analysis
Identify and analyze packaging and labelling regulations for target markets (e.g., EU, US, Asia-Pacific).
Packaging Design & Material Selection
Develop packaging designs that protect device integrity, comply with regulations, and are cost-effective.
Labelling Design & Content Development
Create compliant labels, including CE markings, symbols, user instructions, and safety information.
Sterile Packaging Validation & Testing
Conduct sterilization validation and ensure the packaging maintains device sterility through shipping and storage.
Packaging Integrity & Performance Testing
Perform leak, burst, and durability tests to ensure packaging withstands handling and transportation.
Final Approval & Global Labelling Adaptation
Finalize packaging and labels for regulatory approval and adapt them for global market needs.
100%
Compliance with ISO 11607 & FDA Standards
20%
Reduction in Time-to-Market
0
Non-Conformities in Packaging Audits
Frequently asked questions
We work with a wide range of materials, including medical-grade plastics, foams, films, and laminates, chosen based on device requirements and regulatory standards.
Yes, we offer solutions for both sterile and non-sterile packaging, ensuring that all devices are properly protected and meet the required validation standards.
We analyze regulatory requirements for each target market (e.g., EU, US, APAC) and ensure that all packaging and labelling meet the necessary compliance guidelines, including CE marking and FDA regulations.