Package Validation Services
Ensure the ultimate sterility, integrity, and compliance of your medical packaging with our rigorous ISO 11607 testing protocols.
Medical device packaging is the first line of defense against contamination. A compromised sterile barrier system doesn’t just mean a product recall; it puts patient lives at risk.
Our comprehensive package validation services simulate extreme environmental and physical conditions, providing you with undeniable proof that your packaging can withstand the worst-case scenarios from manufacturing to the operating room.
Qualitech International acts as your official European Authorized Representative, ensuring regulatory compliance, communication with Competent Authorities, and continuous post-market support. We protect your regulatory interests while enabling smooth and secure access to the EU market.
Flawless Packaging with Regulatory Accountability
We partner with you to eliminate packaging vulnerabilities, ensuring your products meet the strict scrutiny of Notified Bodies (MDR/IVDR) and the FDA.
- Full compliance with ISO 11607-1 and ISO 11607-2.
- State-of-the-art environmental and transit simulation.
- Rapid and accurate shelf-life determination.
- Comprehensive testing protocols and audit-ready reports.
- Expert remediation support for packaging failures.
What We Offer ?
Equipped with the latest climatic chambers and precision physical testing rigs to ensure maximum accuracy and reliability.
Subject packaging to extreme drops, vibrations, and compression to ensure survival through global shipping networks (ISTA/ASTM).
Utilize dye penetration and visual inspection to guarantee your sterile barriers are flawlessly sealed and physically robust.
Precision peel strength and burst testing to measure the mechanical force required to open the sterile barrier system.
Expose packaging to extreme temperature and humidity fluctuations to evaluate material performance under severe climates.
We write and execute robust validation protocols, delivering comprehensive, audit-ready final reports for your technical file.
Why Choose Qualitech International ?
Advanced Facilities
Equipped with the latest climatic chambers and precision physical testing rigs to ensure maximum accuracy and reliability.
Rapid Turnaround
We understand that time-to-market is critical. We deliver highly accurate testing results within optimized, predictable timeframes.
Unmatched Expertise
Deep understanding of ISO 11607 and MDR requirements, guaranteeing your reports satisfy the highest regulatory scrutiny.
