General Medical Devices
General medical devices (e.g., surgical instruments, implants, syringes, wound dressings, catheters) play indispensable roles. Ensuring their safety, reliability, and performance is paramount. Failure to meet stringent performance, chemical, and biological safety standards can have severe consequences. As a leading provider of medical device testing services, Meditronics is dedicated to offering comprehensive and reliable testing solutions for general medical devices.
At Meditronics (a brand of STEMart), we understand the complexities involved in testing general medical devices. With our extensive experience and expertise in the field, we are equipped to handle a wide range of testing requirements. Our state-of-the-art laboratory facilities and advanced testing equipment enable us to conduct precise and accurate evaluations. We adhere to internationally recognized standards and guidelines to ensure that our testing processes are rigorous and reliable. Our team of highly qualified professionals, comprising experts in materials science, engineering, and biology, works diligently to provide you with comprehensive testing services. We are committed to helping manufacturers and researchers ensure the quality and safety of their non - active medical devices, facilitating their smooth entry into the market and ultimately contributing to improved patient outcomes.
Testing Service & Standards
| Testing Category | Testing Content | Testing Standards |
| Biological Evaluation | Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Systemic Toxicity (Acute/Subacute/Chronic), Genotoxicity, Implantation, Hemocompatibility, Carcinogenicity, Reproductive/Developmental Toxicity | ISO 10993 series |
| Chemical Characterization | Material Composition Analysis, Extractables & Leachables (E&L) Studies, Degradation Product Profiling, Residuals Analysis, Elemental Impurities, Surface Characterization |
ISO 10993-18:2020 USP <661> USP <1663> ICH Q3D |
| Physical Performance Testing | Mechanical performance: Tensile/Compression/Flexural Strength, Hardness, Density, Viscosity; Functional performance: Dimensional Accuracy, Fatigue/Durability, Barrier Properties |
ISO 527 ISO 604 ISO 178 ASTM D638/D790 ISO 21535:2020 ASTM F2097 |
| Shelf Life Verification | Accelerated Aging Studies, Real-Time Aging Studies, Functionality Verification, Packaging Integrity Validation |
ASTM F1980-21 ISO 11607-1:2020 |
| Microbiological Testing | Bioburden Testing, Sterility Testing (Membrane Filtration/Direct Transfer), Bacterial Endotoxins (LAL/BET), Antimicrobial Efficacy |
ISO 11737-1:2018 ISO 11737-2:2019 USP <71> USP <85> |
| Sterilization Validation | Process Validation: EO Sterilization Validation, Radiation Sterilization Validation, Steam Sterilization Validation; Performance Qualification: Dose Audits, Residuals Analysis |
ISO 11135:2014/Amd 1:2019 ISO 11137-1:2022 ISO 17665-1:2022 AAMI TIR28:2016 |
Tested Device Types
Our expertise encompasses a broad spectrum of non-active devices, including but not limited to:
- Surgical Instruments and Implants
- Dental Materials and Devices
- Ophthalmic Devices
- Wound Care Products (Dressings, Sutures)
- Catheters and Cannulae
- Injection Pens, Syringes, Needles
- Orthopedic Devices
- Contraceptive Devices
- Dialysis Devices
- Patient Care Equipment
Key Features
Scientific & Regulatory Support
Expert guidance on test strategy development, protocol design, and regulatory pathway navigation.
Global Regulatory Expertise
Deep understanding of FDA, EU MDR/IVDR, ISO, CFDA/NMPA, and other international requirements.
State-of-the-Art Laboratories
Equipped with advanced instrumentation for precise and reliable data.
End-to-End Solutions
From material selection support to final validation reports for regulatory submission.
Accelerated Timelines
Efficient project management and optimized testing protocols.
Customizable Testing
Tailored programs to meet specific device requirements and risk profiles.
Partner with Meditronics to confidently navigate the demanding regulatory landscape and bring your safe, effective, and compliant non-active medical devices to market. Contact us today to discuss your specific testing requirements.
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