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Consulting |
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Our years of expertise with the medical device industry, biomedical labs and pharmaceutical industries give us a strong skill set with which we can help our clients in designing devices, developing process automation, and identifying regulatory requirements. |
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Medical Devices |
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We can provide our expertise in the development of medical devices from design phase to a fully-developed product. Our solutions will include design, development processes, validation, testing, and adherence to regulatory requirements. We will assist you in speeding the process of launching a medical device to the market by at least 40% with the help of our innovative solutions. We will work with you to get FDA approval, ISO certification, and clinical trials. BioRazor is committed to providing service of the highest quality and is dedicated to the success of its clients. |
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Biomedical labs and Pharmaceutical Industries |
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BioRazor' years of experience with process automation will help you in getting required throughput, accuracy, and the most optimized process layout. Our solutions are extremely innovative, This innovative spirit will give you not only visualization of layouts but also identify limitations of the hardware, its electrical, and controls layout. So you can really see its entire process in virtual form. Our experience with camera controls will provide you the best available solutions in the market. |
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Regulatory Requirements |
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In the medical device industry and biomedical labs, regulatory requirements are very strict and seem a big hurdle for OEMs. Our purpose is to work with you to get FDA approval, technical information to support IDE (Investigational Device Exemption) applications 510(k) and IRB (Institutional Review Board) approvals. We can also write your 510(k) for you, or refer you to an associate. We will also help you launch your medical device in the market by working with you on Pre-Market Notification submissions, PMA (Pre-Market Approval) applications. |
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