Biomechanical Engineering is the application of physics and mechanical engineering to the human body. We apply principles of engineering mechanics to biological systems. We use the tools and approaches of mechanical engineering while taking into consideration regulatory requirements. Our biomechanical engineers have the right experience and background working in nonclinical, preclinical, clinical and regulatory drug and device development programs. All of our biomedical consultants and engineers are either experienced pharmaceutical/biotechnology professionals or former regulatory authority managers.

Here is a brief list of services we specialize in:

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• BIOMECHANICAL DESIGN AND DEVELOPMENT using advanced software tools such as Solidworks, AutoDesk Inventor as well as laboratory tools such as rapid prototyping, mechanical tests…etc.

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• BIOMECHANICAL ANALYSIS: Our biomechanical engineers assist in understanding accidents and injuries with respect to the mechanisms involved and how they may or may not be related to a claimed injury event. AGS-Engineering biomechanical engineering experts understand how those injuries occur or more specifically how the human body reacts to externally applied and internally generated forces. In a biomechanical analysis we examine the factors in an incident to determine if and/or how an injury occurred, how severe it is, and if there was a way to mitigate the injury.  Specifically, we analyze how the human body responds to forces and stresses to determine the potential for injury.  In an injury causation analysis we compare the mechanical forces involved in the incident with the body's injury tolerance.  For injury to occur, loads must be applied to tissue in a certain manner and with enough force to exceed the strength and tolerance of the tissue.Our biomechanics experts have performed countless analyses over the years and use a teaching approach to explain technical details in an easily understandable format. 

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• BIOMECHANICAL TESTING: We have access to a facility that is staffed and equipped to support our experts and clients with complex, case-specific testing, research and experimentation.  We perform a wide variety of testing, research and experimentation related to human acceleration, acceleration tolerance, and acceleration protection.  Test data are collected, analyzed and compared to the forces and accelerations in the alleged injury producing event to determine if the event could have resulted in the alleged injury.

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• PROJECT MANAGEMENT: AGS-Engineering project management team can work as a primary resource and point of communication for the client’s biomechanical design & development project. Our experienced project managers can provide leadership and direction to the project team, including the development of comprehensive project plans that include detailed timelines and lists of deliverables.

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• REGULATORY SERVICES: Our regulatory consulting services include scientific advice, regulatory strategy in the US and abroad, regulatory writing, submission strategies, clinical trial applications, maintenance and support, pharmacovigilance processes, marketing applications, pre and post-approval activities

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• SAFETY SERVICES to assist in the development of new biological and medical devices, as well as in all phases of clinical research and post-approval marketplace.

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• MEDICAL DEVICE AND EQUIPMENT FAILURES: AGS-Engineering biomedical engineers assist clients and juries, to understand the root causes and effects of failures of medical equipment in hospitals, medical offices or homes; and of medical devices such as replacement joints, fracture fixation devices, braces and pacemakers. Our biomechanical experts have the experience to analyze mechanical effects, forces, stresses….etc. that can cause potential failure in devices and equipment. When an implanted medical device or biomedical equipment fails, there generally is another painful and expensive surgical procedure or yet even worse, catastrophic injuries or death. Our experts help determine the root causes of such failures, whether they occurred due to poor design, manufacturing or installation defects or misuse. Other non-implanted medical devices, such as knee braces or artificial limbs, can also fail, resulting in further injury. We review such failures, assess the root causes and evaluate the reported injuries from both a biomedical and biomechanical perspective. We also evaluate whether the regulatory process used to approve the equipment was appropriate for the use of the product and if the product was applied in the manner intended.

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• BIOMEDICAL TECHNOLOGY AND INTELLECTUAL PROPERTY: With new biomedical products entering the market almost daily, disagreements arise as to ownership of that new technology, and litigation commonly ensues. We assist in intellectual property disputes when two different entities lay claim to the same technology by evaluating patents in light of the technologies and their use. We also assist clients in filing patents and protecting of their intellectual property.

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• EXPERT WITNESS AND LITIGATION in biomedical device and equipment failures. We also provide litigation consulting specializing in biomechanics related to injury analysis for vehicle collisions, accidents in the workplace, and recreational and boating activities, off-road vehicles. Our biomechanical engineering expertise encompasses biomechanics, human anatomy and mechanics, which provide a basis for our consulting, expert witness and litigation work in which we determine the types of forces and movements that a person would have experienced in a specific incident, assess the types of trauma the various tissues would sustain, and develop a biomechanical model of injury. In addition, we conduct analyses of potential injury mechanisms for individuals interacting in specific person-machine environments such as one might encounter in the work place, repetitive motion injuries and others. AGS-Engineering biomechanics experts have extensive experience in injury causation and have been designated as experts during litigation proceedings to provide expert analysis and testimony regarding the causal relationship between accident forces and injuries in traffic collisions, workplace injuries and others.

 

If you have a challenging biomechanical design and development project, contact us and we will be glad to discuss your project and have it evaluated by our seasoned subject experts.

 

If you are mostly interested in our general manufacturing capabilities instead of engineering capabilities, we recommend you to visit our custom manufacturing site http://www.agstech.net

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Our FDA and CE approved medical products can be found on our medical products, consumables and equipment site http://www.agsmedical.com