Global Instrumentation has extensive development experience in proprietary signal processing circuitry, algorithms, and data analysis system software. Our analysis software can be run on a variety of systems ranging from embedded systems to laptops, tablets, and smartphones. Global Instrumentation specializes in developing data acquisition and analysis software for the Microsoft Windows and .NET environments as well as supporting Linux, Android, and real-time operating system environments.

Our expertise includes the use of internet web-based interfaces to remote instruments and leveraging the rich feature set MS Azure and Amazon Web Service cloud environments to create a design platform that is extendable. If desired, we can deploy our software solutions on the partner's internal network environment or offer hosting services.

Using this platform, Global Instrumentation provides design services to companies who wish to sell a customized version of our products under their own name, or who wish to use our design as the backbone for a new product. Based on the need, we can provide sub-assemblies, turn-key systems, or a platform upon which a company’s application can run.

GI can provide support in the areas of:

• Signal acquisition and processing
• Diagnostic analysis tools & algorithms
• System architecture
• Networking
• Integration of 3rd party signal processing modules or peripherals
• U.S. and European regulatory testing

As a manufacturer of medical devices, we are very familiar with the boundary conditions for approval of medical devices. We are an FDA registered manufacturer and ISO 13485:2016 certified.

So that you can fully concentrate on your core expertise, we will stand by you as a competent partner for all approval matters. We will support you in go-to-market planning for your product and prepare it for approval for national and international markets. On several occasions, we have approved products to 510k standards for U.S. launch and CE Mark for EU markets.

Our regulatory service offering includes:

• Advice for approval related issues in product development
• Standards research
• Compilation of technical documentation and review of existing documents
• Support in the areas of risk management (DIN EN ISO 14971), software development process (ISO 62304) and serviceability (DIN EN ISO 62366)
• Creation of accompanying documents
• Communication with test laboratories and Notified Bodies
• Verification of compliance with the essential requirements of the MDD
• Creation of applications for approval

As an experienced development service provider, we know exactly what is important in the implementation phase of manufacturing, the manufacturing process, product storage, and shipping of medical equipment. Therefore, we can support you with our expertise and offer intelligent and comprehensive supply chain management with innovative and reliable production and logistics solutions. We rely on the cooperation with certified national partners and suppliers, as well as the final assembly and testing which we conduct in-house. Additionally, we are experienced in working with outside certified manufacturing facilities to support technology integration and on-going sustaining technical support.