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Medical device projects are very specialized, particularly if the device is FDA regulated. Great care must be taken in the planning, execution, and documentation of the software development process. At Gale Force we have been developing medical devices for many years and are experts at engineering firmware and software to meet IEC 62304, ISO 13485, FDA QSR 820 standards.

We often work as an extension of our clients' own product teams, but are equally comfortable taking a project from start to finish independently. For some clients with whom we are closely aligned, we serve as their complete technical product development team. We are accustomed to using our clients' quality system, or we can use our own internal, ISO-compliant quality system.

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Blood Glucose Meters

Medical Device

Gale Force engineers have worked over a long period as a part of the client's engineering team to produce multiple FDA-regulated blood glucose meters used for patient testing in diabetes care. These devices are typically submitted to the FDA for approval before going to market. Our engineers have written various device drivers including graphics LCD displays with graphics libraries, USB communication, as well as, screen navigation and medically critical algorithms. These meters have been developed for multiple processor platforms with architectures which utilize a real-time operating system and those that do not.

 

 

 

 

FDA Remediation

Medical Device

Our engineers performed a full remediation of an FDA-regulated medical device to correct software deficiencies and bring the software development life cycle process and documentation into compliance with International Standard IEC 62304. As part of the process a software development plan, software test plan, requirements documents, FMEA document and software unit and integration test protocols were written. The test protocols were executed and documented and a formal code review was performed.

 

 

 

 

Nurse Call System

Medical Device, IoT

Several years ago a small business on a shoestring budget came to Gale Force with a partially implemented emergency nurse call system. The business had no in-house development capabilities and had lost the contractor working on the project. We completed the system which originally consisted of a Silverlight web application and a multi-threaded server application, including a WCF layer and multiple interfaces to off-the-shelf alert signaling devices.

We continue to serve as the company's development team and have helped them continually advance their product and update its underlying technologies over time.

 

 

 

 

Mass Spectrometer Sampling Device

Medical Device

The client is developing innovative metabolite profiling for use in detecting the presence and reoccurrence of cancer at earlier stages than currently commercially available tests.

Gale Force Software engineers have been working with this early-stage company to develop a software application that has made the process of analysis and algorithm refinement more efficient. This is not only helping the client’s research and development efforts but will also be the foundation for an eventual commercial application of the technology.

 

 

 

 

DNA-Profile Analysis and Matching System

Medical Device

Gale Force Software has developed a private DNA-Profile matching technology called SmallPond. It provides organizations with the ability to maintain their own private database of DNA-Profile information and provides for efficient matching of new DNA- Profile data against the database to assist in the generation of leads and/or the identification of individuals.

SmallPond’s proprietary search algorithm allows match stringency parameters to be modified as needed without significantly degrading match performance, thereby supporting efficient familial screening. Benchmarks show the application matching against a 10,000,000+ Profile database in ~3 milliseconds. SmallPond™ is designed to be deployed and managed over the Internet, using traditional security measures to protect access to system functions and data and to prevent the unauthorized viewing of web traffic.

 

 

 

 

iPad Analyzer Service Tool

Medical Device

Gale Force Software was engaged to develop an application for the Apple iPad that makes the iPad an external status monitor/remote service tool for a clinical chemistry analyzer.

The application supports the client’s proprietary serial protocol, giving the iPad full access to the analyzer in order to give technicians the ability to control the low-level functions of an embedded instrument system wirelessly. Users can run manufacturing tests and diagnostics for complex instruments in the field as well as remotely initiate complex motions through the use of fully configurable scripts.