Simple Subcontractor Agreement Template Word

Sunday, December 12th 2021. | Sample Templates

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Test System Engineering for Medical Devices: A Guide

Originally Published MDDI January 2002 Test System Engineering for Medical Devices: A Guide

Originally Published MDDI January 2002 TEST SYSTEMS TEST SYSTEMS Test System Engineering for Medical Devices: A Guide Test System Engineering for Medical Devices: A Guide Developing test systems for R&D through production requires a combination of preparedness and ongoing evaluation. Developing test systems for R&D through production requires a combination of preparedness and ongoing evaluation. Tore Johnsen Tore Johnsen A large number of medical device manufacturers use automated test and measurement systems during each stage of the product cycle, from R&D to production testing. These systems play an important role in improving the quality of products and helping speed them to market. Purchasing the test equipment is often less expensive than putting it into use; it can cost more to develop the software to run a system than to purchase the instrumentation. Many companies choose to outsource all or a portion of their test system development. Whether it’s done internally or by an outside vendor, the critical factors for success remain the same: maintaining good communication between developer and client, following an efficient development process, selecting appropriate development tools, and recruiting people with the skills to do the job correctly. A large number of medical device manufacturers use automated test and measurement systems during each stage of the product cycle, from R&D to production testing. These systems play an important role in improving the quality of products and helping speed them to market. Purchasing the test equipment is often less expensive than putting it into use; it can cost more to develop the software to run a system than to purchase the instrumentation. Many companies choose to outsource all or a portion of their test system development. Whether it’s done internally or by an outside vendor, the critical factors for success remain the same: maintaining good communication between developer and client, following an efficient development process, selecting appropriate development tools, and recruiting people with the skills to do the job correctly. This article provides a broad overview of test and measurement system development for the medical device industry. Included is a discussion of commonly used instrumentation and tools and an overview of the skills and practices necessary for successful test system development. This article provides a broad overview of test and measurement system development for the medical device industry. Included is a discussion of commonly used instrumentation and tools and an overview of the skills and practices necessary for successful test system development. HOW AND WHY TEST SYSTEMS ARE USED HOW AND WHY TEST SYSTEMS ARE USED In the medical device manufacturing industry, test and measurement systems are used for a wide range of purposes. Some examples include those developed to: Demonstrate proof-of-concept prototypes for new equipment used to cauterize heart tissue. Research the shrinkage of new dental filling materials as they cure. Verify that such implantable devices as pacemakers and neurostimulators function according to specifications. Condition and test batteries for implantable devices. Simulate the pressing of buttons, turning of knobs, collecting of patient data, and other functions while monitoring and recording a blood-treatment machine’s operation. In the medical device manufacturing industry, test and measurement systems are used for a wide range of purposes. Some examples include those developed to: Demonstrate proof-of-concept prototypes for new equipment used to cauterize heart tissue. Research the shrinkage of new dental filling materials as they cure. Verify that such implantable devices as pacemakers and neurostimulators function according to specifications. Condition and test batteries for implantable devices. Simulate the pressing of buttons, turning of knobs, collecting of patient data, and other functions while monitoring and recording a blood-treatment machine’s operation. In order to carry out these tasks, the required systems must be capable of performing such functions as automatically controlling switches and relays, setting and reading temperatures, measuring or generating pulse widths and frequencies, setting and measuring voltages and currents, moving objects with motion control systems, using vision systems to detect misshaped or missing parts, and others. The medical device industry’s need for test equipment and related sensors and technologies is as varied as the industry itself. No matter what the specific need, however, compliance with the quality system regulation is mandatory. In order to carry out these tasks, the required systems must be capable of performing such functions as automatically controlling switches and relays, setting and reading temperatures, measuring or generating pulse widths and frequencies, setting and measuring voltages and currents, moving objects with motion control systems, using vision systems to detect misshaped or missing parts, and others. The medical device industry’s need for test equipment and related sensors and technologies is as varied as the industry itself. No matter what the specific need, however, compliance with the quality system regulation is mandatory.

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