Physical & Mechanical Testing for Medical Device
Ensuring Performance, Safety, and Compliance
Reliable performance and safety are paramount when it comes to medical devices and Combination Devices. Our Physical & Mechanical Testing services are designed to rigorously evaluate every aspect of your product, from durability and strength to the stability and functionality of critical components.
By adhering to industry-leading standards such as ISO 11608, ISO 11040, and ISO 80369, we provide comprehensive testing solutions that ensure your devices meet the highest regulatory and quality expectations.
Whether you need design verification testing, stability studies, or mechanical assessments, Cormica offers a range of advanced testing methodologies tailored specifically for the medical device industry. Our team of experts work closely with you to identify the most appropriate tests to validate your product’s integrity, offering a pathway to faster approvals and market entry. With a global footprint and a commitment to continuous improvement, we ensure your devices are ready to perform under real-world conditions, enhancing patient safety and healthcare outcomes.
Our Physical and Mechanical Testing Services for Medical Devices, Combination Products and Pharmaceuticals
Design Verification Testing
- ISO 11608
- ISO 11040
- ISO 80369
- Tensile & Compression Tests
- Pressure & Vacuum Tests
Design Validation Testing
- Tensile & Compression Tests
- Pressure & Vacuum Tests
Needle Injection Systems
- Design Verification Testing
- ISO 11608
- ISO 11040
- ISO 23907-1
- ASTM D6653 Air Transport Simulation
- ISO 80369
Parental Containers
- ISO 11608-3
- ISO 8871-5
- ISO 11040-8
- USP 1207
- Dye Solution Tightness
- Trace Gas Detection
Physical Testing / Mechanical Testing
- Tensile & Compression Tests
- Pressure & Vacuum Tests
- Flow Rate
- Attachment & Detachment Forces
- Pre-Conditioning
- ISO 80369
- Safety Feature Confirmation
- Sharps Bins
- ISO 23907-1
- Torque & Axial Forces
- Penetration Tests
Device Stability Studies
- Real Time & Elevated Conditions
- ISO 11608
- Tensile & Compression Tests
- Attachment & Detachment Forces
- Torque & Axial Forces
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The timeline for physical and mechanical testing of medical devices depends on the specific tests required, such as tensile, compression, or flow rate tests. We offer flexible testing schedules, with standard testing turnaround times ranging from 1-2 weeks.
Mechanical testing and functional testing is crucial for a wide variety of medical devices, including needle injection systems, drug delivery devices, parental containers, and implantable technologies. Cormica specialises in testing to ensure device durability, performance, and compliance with industry standards like ISO 11608, ISO 11040, and USP 788.
For mechanical testing of medical devices, we follow several key ISO standards, including ISO 11608 for needle-based systems, ISO 11040 for prefilled syringes, and ISO 80369 for small-bore connectors. Our adherence to these international standards ensures your device meets global regulatory requirements.
Design verification testing ensures your medical device is built according to design specifications, while validation testing confirms it meets user needs and regulatory standards. At Cormica, we offer comprehensive physical and mechanical testing to support both design verification and validation processes, helping ensure your device is safe, effective, and compliant.
Device Testing Related Resources
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