Enhancing Your Product Development Journey
At iuvo Bioscience, we specialize in providing comprehensive medical device pre-clinical and clinical testing services to support your product development efforts. With our deep knowledge and expertise in the field, we offer a wide range of testing services that adhere to the highest quality standards and lab practices, ensuring the safety and efficacy of your medical devices.
Comprehensive Testing and Evaluation
Our dedicated team of scientists are experienced at handling nearly every aspect of medical device pre-clinical testing and evaluation. We offer a portfolio of comprehensive testing services tailored to meet the unique needs and goals of your development project – everything you need to help bring your product to market safely and as efficiently as possible.
Performance and Safety Testing
Ensuring the performance and safety of your medical device is critical for regulatory approval and commercialization success. At iuvo Bioscience, we conduct rigorous testing to evaluate factors such as mechanical properties, biocompatibility, sterility, and durability. The technology and tools in our clinical laboratory allow us to simulate real-world conditions, delivering the accurate, reliable data you need to support your product development decisions.
Biocompatibility Studies
Biocompatibility is a critical aspect of medical device development. Our expert team performs the full gamut of ISO 10993 biocompatibility studies according to international standards and guidelines, assessing the interaction of your device with biological systems. We employ a range of in vitro and in vivo tests to evaluate cytotoxicity, genotoxicity, hemocompatibility, and implantation response. Our comprehensive approach ensures that your medical device meets the necessary biocompatibility requirements.
Validation and Verification
To meet regulatory requirements and ensure the effectiveness of your medical device, thorough validation and verification are essential. Our team assists you in developing and executing validation and verification strategies, including design verification and process validation. Utilizing advanced testing methodologies and the industry best practices, we can help you demonstrate the reliability, performance, and safety of your medical device, and provide the critical data you need to support it.
Regulatory Support
Navigating the complex regulatory landscape can be challenging. At iuvo Bioscience, we have a critical understanding of and extensive experience working with the requirements of various regulatory agencies and can provide valuable support throughout the regulatory submission process. Our team is well-versed in global regulations and guidelines, including FDA, ISO, and CE requirements – including ISO 10993, 10993-18 and MHLW. We offer comprehensive documentation support, including preparation of all pre-clinical and clinical data, technical files and assistance in developing regulatory strategies.
Collaborative Partnership
At iuvo, we understand the importance of collaboration and effective communication in successful medical device development. In most cases, you’ll work directly with our scientists, to ensure a transparent and efficient process. Our high-touch approach ensures you are as actively involved in the testing process as you want to be. Have a project that requires custom protocols? Just as every device has its unique properties, so too can your testing protocols. Iuvo will customize your pre-clinical testing regimen to ensure we deliver the data outcomes you need to succeed.
Our Medical Device Testing Services
Analytical Method Development and Validation Testing
Antimicrobial Effectiveness Testing
Bacterial Endotoxin Testing
Bioburden Testing
Biocompatibility Testing
Biological Reactivity Testing
Chemical Characterization Testing
Compendial Testing
Cytotoxicity Testing
D Value / Population Testing
Environmental Monitoring and Assessment Testing
Ethylene Oxide Residual Testing
Genetic Toxicology Testing
Hemolysis Testing
Heterotrophic Plate Count Testing
Intramuscular and Subcutaneous Implantation Testing
Irritation / Intracutaneous Reactivity Testing
Microbial Limits Testing
Ophthalmic – Medical Device Testing
Package Integrity Testing
Pyrogen Testing
Regimen Testing
Reusable Medical Device Testing
Sensitization Testing
Sterility Testing
Subchronic / Chronic Toxicity Testing
Systemic Injection / Toxicity Testing
Choose iuvo Bioscience for Your Medical Device Services
By choosing iuvo Bioscience as your partner research organization for medical device services, you benefit from our experience and expertise, high-touch approach, and commitment to delivering excellence. We are dedicated to providing the most accurate and reliable data that supports your product development journey and regulatory compliance.
Contact Us Today
If you’re seeking comprehensive medical device services, look no further than iuvo Bioscience. Our experienced team is ready to assist you with testing, evaluation, and regulatory support to ensure successful commercialization of your medical device. Contact us today to discuss your project and learn how our expertise can help you get to market fast.
