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For a printer-friendly version, click here. To access our Medical Device catalog of services, click here. In-Life Services: Custom Medical Device and Materials Testing Frequently medical devices require testing beyond the standard ISO/FDA 10993 testing methods. These tests may be performed in order to better understand material performance, device performance and design, implant methodologies and implant training. Analysis maybe performed on devices at all stages of development, however for materials biocompatibility, material performance and implant technique development, it is strongly recommended that tests should be conducted with final sterilized product or representative samples according to objectives of the testing. AppTec is capable of supporting GLP, Non-GLP and R&D device and material testing. Because of the diversity of medical device design and usage, AppTec recognizes that each device and situation be evaluated with the customer and a systematic approach be developed that meets all requirements for successful project completion. This analysis may include: • Model Identification • Regulatory Consultation • Model Evaluation or Development • Device Performance and Evaluation • Study Scheduling • Histopathology Complete toxicology and biocompatibility/safety testing services are also available. AppTec Capabilities Acute Implantation Small and Large Animal Implants Subcutaneous Intramuscular Intraperitoneal Thoracic and Abdominal Vascular Chronic Implantation Small and Large Animal Implants Subcutaneous Intramuscular Intraperitoneal Thoracic and Abdominal Vascular Variety of Animal Models Mice Rat Guinea Pig Rabbit Dog Pig Goat Sheep Custom Research Protocols Protocol Research Protocol Development Protocol Review & IACUC Approval GLP, Non-GLP and R&D Studies Study Conduction Optimum Animal Model / Test Selections Scheduling Study Direction Protocol and Regulatory Compliance Data Collection, Analysis & Archiving Auditing Functions Final Report AppTec Services Surgical Expertise Necropsy and Tissue Collection Pharmacokinetic Analysis Animal Care and Veterinary Services Histopathology / Immunochemistry Clinical Pathology Chemistry – 18 Test Parameters Hematology – 14 Test Parameters AppTec Expertise Device/Drug Combinations Device/Tissue Combinations Device Implants Single-Use Device Evaluations Hemostasis / Wound Healing Orthopedic Devices Bone Defect Studies Bone Stabilization Implants Induction Studies Cardiology Devices Catheters and Coronary Stents Atherectomy Devices Pacing and Defibrillation Leads Chronic Sensors Fabrics and Vascular Grafts Research Devices and Materials Monoclonal Antibodies Drug Metabolism Allograft, Autograft & Xenograft Implantation Thrombogenicity Neuro Stimulation and Device Placement Bacterial Challenge of a Device Implant
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