Physical, Functional & Packaging Testing
Medical Device Physical & Functional Testing
Accelerate your device’s path to market with Cormica’s rigorous Physical & Packaging Testing solutions. Our experts validate your device’s functionality, durability, packaging integrity, and safe transport, ensuring product performance, patient safety, and regulatory compliance throughout development and distribution.
Cormica’s Physical & Packaging Testing services are conducted in accordance with ISO 17025 standards. This accreditation underscores our dedication to reliable data, robust testing protocols, and compliance with industry-leading practices.
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Cormica Device Testing & Packaging Validation Solutions
Device Verification and Validation
- Luer Lock Dimensional Testing
- Break Loose / Glide Force Testing
- Needle Cap Removal Force Testing
- Injection Force Testing
- Catheter Performance Testing
- Infusion Set Testing
- Dose Accuracy Testing
- Wound Dressing Performance Testing
Specific Device Testing:
- ISO 11608 – NIS Need Injection system Testing
- ISO 11040 – Pre-filled Syrgine Testing
- ISO 80369 – Small Bore Connector
- Catheter Testing
Regulatory Standards:
- USP: <1207>
- EN: 12439, 13868
- BS: 6196
- ISO: 11607, 11608, 11040, 80369, 23907-1, 8871-5, 20695, 20696, 20698, 10555, 11070
- ASTM: F1140, F1929, F1980, F2096, F2338, F88, D4169
- ISTA: 3
Transit / Packaging Validation & Verification
- Transit & Distribution Simulation
- Real-time / Accelerated Ageing & Stability Testing
- Packaging Validation & Verification
- Bubble Leak Test (Internal Pressurisation)
- Peel Strength Testing
- Dye Penetration Testing
- Burst Testing
- Container Closure Integrity Testing (CCIT)
- Vacuum Decay
- Blue Dye Immersion
- Hydrogen Leak Detection
- Microbial Ingress
Regulatory Standards:
- USP: <1207>
- ISO: 11607-1
- ASTM: F1140, F1929, F1980, F2096, F2338, F88, F1886, F1140, F2054, D4169, D4169, D7386, D6653
- ISTA: 3A
Related Physical Device Testing Resources
Meeting Global Standards for Medical Device & Packaging Testing
Cormica’s Physical & Packaging Testing services adhere to the most stringent regulatory requirements and industry best practices, including:
Device Performance & Safety Testing Standards:
- ISO 11608 Series (Needle-based injection systems)
- ISO 11040 Series (Prefilled syringes)
- ISO 80369 Series (Small-bore connectors for liquids and gases)
- ISO 7864 (Sterile hypodermic needles)
- ISO 11607-1 and ISO 11607-2 (These critical standards focus on packaging for terminally sterilised medical devices.)
- EU Medical Device Regulation (MDR) (Ensures compliance with the MDR’s stringent requirements for safety, performance, and documentation throughout your device lifecycle.
Investing in standards-based testing is an investment in patient safety and the success of your medical devices.
