Medical Device Testing Services
Ensuring Quality, Safety & Compliance for Drug-Device Combinations and Class II/III Devices
At Rarebio Scientific, we offer a comprehensive suite of medical device testing services focused on drug-device combination products and regulated Class II and Class III devices. Our services are designed to meet the stringent requirements of global regulatory bodies such as the US FDA, EMA, and CDSCO.
Our Specialized Focus
We specialize in benchmark testing and performance evaluation of drug-device combination products, including:
- Autoinjectors
- Prefilled Syringes (PFS)
- Pen Devices
- Ophthalmic Packaging Systems
- Nasal Spray Devices
- Transdermal Patches & Microneedle Devices
Our advanced analytical team delivers precision testing for complex drug-device systems, ensuring safety, functionality, and regulatory compliance. Using validated methods and state-of-the-art instrumentation, we assess performance, durability, and patient usability.
This integrated approach supports faster development timelines while meeting stringent global standards for pharmaceutical and medical device products.
Functional Testing
Ensuring device performance, accuracy, and user safety.
E&L Studies
Identifying and assessing extractables and leachable.
Packaging Testing
Verifying integrity, strength, and durability of packaging.
Core Testing Capabilities
✅ Functional & Performance Testing
• Delivery force & actuation force
• Injection time and dose accuracy
• The plunger breaks loose and glides with force
• Needle shield removal force
• Leak testing and container closure integrity
• Penetration force and needle safety testing
✅ Extractables & Leachables (E&L)
• Comprehensive studies using GC-MS, LC-MS/MS, and ICP-MS
• USP <1663> and <1664> compliant methodology
• Risk-based assessment for drug-container interactions
✅ Packaging & Container Testing
• Container closure integrity (CCI) – deterministic & probabilistic methods
• Burst, creep, and seal strength tests
• Label adhesion, print durability, and packaging integrity under stress
• Accelerated and real-time stability studies
✅ Ophthalmic Device Testing
• Drop size & dosing consistency
• Re-closure functionality
• Extractables in eye drop bottles & droppers
• Compatibility studies with ophthalmic formulations
Medical Device Classification Expertise
We provide end-to-end testing services for:
- Class II Devices – Syringes, infusion systems, diagnostic kits, etc.
- Class III Devices – Combination autoinjectors, implantable, critical care delivery systems
Frequently Asked Questions
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1What Types Of Medical Devices Do You Test?
We specialize in testing drug-device combination products such as autoinjectors, prefilled syringes, pen devices, ophthalmic packaging systems, nasal spray devices, transdermal patches, and microneedle devices. We also handle Class II and Class III medical devices, ensuring compliance with global regulatory standards.
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2How Do You Ensure Regulatory Compliance In Testing?
All our testing protocols follow stringent guidelines from the US FDA, EMA, and CDSCO. Our Extractables & Leachables studies meet USP and standards, and our performance evaluations are conducted using validated, risk-based methodologies to meet or exceed regulatory expectations.
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3What Are Your Core Medical Device Testing Capabilities?
Our services include functional & performance testing, extractables & leachable studies, packaging & container testing, and ophthalmic device testing. This covers delivery force, dose accuracy, seal strength, container closure integrity, compatibility studies, and more.
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4Do You Offer Stability And Packaging Integrity Studies?
Yes. We conduct both accelerated and real-time stability studies, along with packaging integrity evaluations such as burst, creep, seal strength, and label durability testing, ensuring your product maintains safety and performance throughout its lifecycle.