Biocompatibility and Devices Research
Biocompatibility is the ability of an implant material to function in vivo without eliciting detrimental local or systemic responses in the body. Prior to their use in human fracture fixation, biomaterials undergo tissue and animal testing to determine their safety and efficacy.
Here at Comparative Biosciences, Inc. We offer a range of safety evaluation and biocompatibility services for medical devices.
CBI’s Biocompatibility Testing Services For Medical Devices
We take pride in the technical depth, experience and breadth of services we offer, while maintaining our focus on putting our clients’ needs first. CBI has the team you can trust to get the job done, regardless of your specific needs, including bringing a new product through research and development, interacting with the Regulators are all part of pre-IND meetings and pre-approval inspections.
Medical Devices Biocompatibility Testing – A Risk-Based Framework for Biocompatibility Assessment
What exactly is a “risk-based approach?”
ISO 14971 defines the term “risk” as “the combination of the probability of occurrence of harm and the severity of that harm.” The standard defines harm primarily as physical injuries and damage to health, but it also includes harm to goods and to the environment.
ISO 14971 is the key to effective risk management for medical devices.
ISO 14971 is the risk management standard for medical devices. This includes software as a medical device and in vitro diagnostic medical devices. It contains a structured approach for effective risk management. The risk-based approach adds the harm resulting from regulatory non-compliance and bureaucracy. It is about weighing the likelihood and the consequence of the identified risks and adapting the expenditure of resources accordingly.
In Vivo Assays
- Acute, systemic, subacute, chronic and carcinogenicity toxicity studies
- Beuhler, Draize and Magnussen-Kligman maximization testing
- Bone, joint, and orthopedic
- Contact lens testing, ISO-9394
- Device-drug combinations
- Device-stem cell combinations
- Dermal, ocular, mucosal irritation testing
- Bone, joint, and orthopedic
- Long-term surgical implantation studies
- Muscle, bone, subcutaneous and intradermal implantation
- Topical, intracutaneous, ocular and primary skin irritation testing
- Pyrogenicity testing
CBI has conducted numerous studies related to dural, amnionic, pericardial and other patches, coated films, sutures, matrices, osteoinduction materials, cartilage regeneration, morselized bone, spinal fusion, bone regeneration and tendon repair. These studies are often customized or unique experiments.
Safety Pharmacology Assays
- Safety Pharmacology: Irwin, respiratory, cardiovascular intravenous irritation, CNS
In Vitro Assays
- Blood compatibility testing (hemocompatibility)
- Cytotoxicity testing (Agar overlay and MEM elution)
- Other in vitro assays
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