In-Vivo Studies for Medical Devices
Medical devices that come into direct or indirect contact with patients must undergo rigorous preclinical in vivo testing to evaluate potential adverse biological responses within the body.
Specializing in these critical evaluations, we conduct studies in full compliance with ISO 10993 medical device guidelines, supporting your path to regulatory approval. From initial design and proof-of-concept to long-term regulatory testing under GLP, Scantox offers comprehensive support to help bring your devices to market safely and efficiently.
Our in vivo studies test medical devices in various applications, including wound care, catheter systems, and other implantable devices. We tailor every study to meet each device’s unique characteristics, ensuring that we evaluate its interaction with living tissues based on the type and duration of patient contact.
Key Service Solutions
Device Implantation Studies
For devices intended to be inserted into the body, such as catheters and biomaterials, we conduct implantation studies to assess their interaction with living tissues. We evaluate acute and chronic effects to ensure the device’s safety and efficacy in real-world medical applications.
Device Extract Testing Procedures
For devices made from materials like plastics, we perform extraction procedures where materials are dissolved or placed in extracts. These extracts are then tested in vivo to detect any toxicological effects.
Subcutaneous Implant Assessments
These studies test devices requiring subcutaneous implantation, such as small pumps or specific drug delivery systems. They are critical for assessing short- and long-term reactions under conditions that simulate clinical use.
Gastrointestinal Device Evaluations
With the increasing focus on device-enabled biologics delivery, we help you explore innovative ways to deliver large-molecule pharmaceuticals. Our gastrointestinal testing addresses the challenges of poor bioavailability in standard oral delivery systems, enabling more efficient drug-device integration.
Early-Stage Proof-of-Concept Support
For more complex or innovative devices, we provide specialized in vivo testing. This includes early-stage proof-of-concept studies, where our scientists place new devices into animal models to assess feasibility, safety, and performance. These pilot studies allow you to refine device designs and evaluate their biological response before progressing to large-scale regulatory testing.
Facilities and Equipment
Scantox’s surgical suites support basic and complex implantation studies, facilitating comprehensive evaluation of devices under various conditions and clinical scenarios. In addition, we use specialized equipment to prepare and process medical devices to ensure rigorous testing standards are met. These capabilities allow you to gain a thorough understanding of how devices perform in practical clinical applications.
Analytical Readouts
Our advanced testing methodologies provide critical data to ensure the safety and biocompatibility of your device:
Histopathology Analysis
Our expert histopathology team provides in-depth tissue analysis to detect inflammatory responses, chronic conditions, and other reactions. This precision is essential for ensuring biocompatibility and meeting regulatory standards.
Limulus Amebocyte Lysate (LAL) Test for Pyrogenicity
To ensure your device is free from endotoxins, we conduct LAL testing to detect bacterial endotoxins. This is critical for confirming that your device is safe and will not cause fever-inducing patient reactions.
Biocompatibility Testing
Furthermore, for devices that come into contact with blood, we offer comprehensive biocompatibility testing to evaluate interactions with blood components. This testing ensures your device does not induce harmful responses such as thrombosis, hemolysis, or other adverse reactions.
Why Choose Scantox?
- Expertise:
Our multidisciplinary team, composed of study directors, veterinarians, and pathologists, has over 25 years of experience conducting sophisticated medical device testing programs. - Flexibility:
Every medical device is unique. We work closely with you to tailor studies to your device type and research needs. Our collaborative approach helps refine devices at the concept stage, leading to optimal outcomes in regulatory studies. - Commitment to Quality:
We maintain the highest data quality and regulatory compliance standards. We operate under GLP conditions and follow stringent quality control processes to support the approval of medical devices for clinical use.
Ensure a strong start for your medical device
Whether you’re developing a medical device, combination product, or drug-delivery system, Scantox is the partner you can count on for reliable, efficient, and precise in vivo testing.
Our team is committed to guiding you through the complexities of the testing process. From single studies to comprehensive test portfolios, we provide the clarity you need to make informed decisions.