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Medical Device Design Services
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Bringing a new medical device to market is an exacting process. In addition to developing the basic technology, there is lots of regulatory work to be done. AB Tech Solution engineers have been successfully brought many medical instruments to market, and can help you bring yours to market at a lower cost than you might expect!
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FDA, EMEA, cGMP, 21 CFR Part 11 Compliance
No job is complete until the paperwork is done. This is especially true for medical devices, which are regulated by the FDA and other agencies. Our engineers have been through the process, and we can assist you with your 10K and other documentation to get your product approved.
Electronics hardware design
We have expertise in designing reliable and robust electronics for medical devices used in both clinical and field work. We will design the electronics to interface with your biomedical sensors, plus accurately & precisely control your pumps, vacuums, LASERs, and displays.
Control and monitoring software design
AB Tech Solution has expertise in writing high-quality, testable, and verifiable software for medical instruments. Our software engineers will make sure your instrument works reliably and consistently over its entire range of requirements
Safety reviews.
We will work with you to conduct the necessary Failure Modes and Effects Analysis (FMEA) and other required safety protocols for both hardware and software.
Customer product training
AB Tech Solution will help you train your customers on proper usage and application of your new device. Making your customers comfortable with using your device is a sure-fire way to generate more sales.
Sales force product training
You cannot make money unless your sales force can effectively sell your new product. AB Tech Solution will train your internal marketing and sales personnel as well as your dealers and distributors on your products, so they can do what they do best – sell
Manufacturing setup and process design
Once your instrument is ready for production, AB Tech Solution's automation engineers will help your production engineers set up your factory for optimal production. Our engineers are skilled in lean manufacturing and Six Sigma quality control techniques.
Enhancement and Continuing Engineering
After your device is on the market, we will work with you to make the improvements and enhancements requested by your customers.
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