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Medical Devices
Absorption Systems offers a broad range of services, experimental models and surgical capabilities to enable preclinical medical device testing. Surgeons and technicians have advanced training in research surgery and have participated in a broad spectrum of device evaluation studies. Our USDA- and NIH-registered, AAALAC-accredited facility located in San Diego is also available for contract vivarium leasing and physician training.
Key Opinion Leaders can learn about and experiment with your medical device in our state-of-the-art training facility. We offer a pre-conference briefing room, large operating room with separate observation suite, and full technical support.
Absorption Systems has the resources and expertise to perform a wide range of preclinical tests of medical devices in our San Diego facility, with the ultimate goal of reaching the stage of 510(k) or PMA submission.
- State-of-the-art surgical suite with observation room
- Available for physician training
- High-resolution digital fluoroscopy imaging system
- Anesthesia systems and physiological monitoring equipment
- NuGenesis (21CFR Part 11-compliant data management system)
- AAALAC accreditation, NIH and USDA registration
- Availability of many preclinical species, with IACUC oversight
- Bioanalytical support for drug-eluting devices
- GLP compliance
Absorption Systems has years of experience with many types of devices, including orthopedic and cardiovascular implants, drug delivery devices (including drug-eluting stents), and devices for wound healing, ophthalmology, tissue engineering, and general surgery.
- Orthopedic devices are generally solid implants, some of which are initially soft (e.g., pastes), that are intended to contact bone and/or muscle and often remain in place long-term. Our experienced staff will consult with you to design an appropriate animal device testing program, taking into account the nature of the device, its component materials, and its intended use.
- Cardiovascular devices are in contact with the heart or circulatory system and can be intended for either short or long duration of use. Biocompatibility testing with blood (soluble and cellular elements) may be indicated, but different devices require different testing programs. For drug delivery devices such as drug-eluting stents, Absorption Systems measures plasma or tissue drug concentrations in-house; bioanalysis can be GLP-compliant or not.
- Preclinical medical device testing for wound healing involves the creation of an appropriate animal device testing model in a relevant species. The animal model and the testing program are customized based on the intended use of the device.
- Ophthalmic devices can be solid or fluid, short- or long-term, and may be intended to elute a small-molecule drug or a biologic. Our experienced staff will work with you to design an appropriate device testing program in a relevant preclinical species, including in-house bioanalysis if indicated.
- Preclinical testing for dental implants, devices and materials is often similar to that for orthopedic implants, with the additional complication that they are exposed to different tissues, salivary enzymes, etc. Working with you, we design a testing program in an appropriate preclinical species.
In our medical device testing facility in San Diego, Absorption Systems performs in vivo preclinical medical device efficacy testing to verify the performance of medical devices. We also perform a variety of biocompatibility tests (a type of device safety testing) with devices and device materials. Where appropriate, study designs comply with relevant FDA and international regulatory standards.
Contact Absorption Systems to schedule your preclinical medical device testing. Absorption Systems is known for rapid scheduling, quick turnaround, and competitive pricing for all types of preclinical in vivo studies.
Related Literature
This assay is used to determine the acute systemic toxicity of a device or device material in mice or rabbits and is required for most medical-grade materials and devices that are intended to make contact with the patient for more than 24 hours.
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These tests assess the local irritation potential of a test material, using sites such as skin or mucous membranes, in rabbits.
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Brochures
Preclinical medical device testing for efficacy and safety
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