Circuit Check’s medical device testing ensures that quality medical devices are produced quickly and cost-effectively, while managing necessary information data tracking. We know developers of medical device products need a test solutions partner to help solve some of the most complex medical equipment testing challenges. Circuit Check partners with these developers to eliminate potential test risks and ensure the test system is built with the highest quality and reliability.
Medical
Creating a Healthy Future via Medical Device Testing
Medical electronic products have enabled trained technicians, physicians, and biotechnologists to not only improve life expectancies, but also provide important data for ground breaking research and analysis. Manufacturers are tasked with developing the most efficient product while facing a growing number of transitions including: a push towards more sophisticated technology, the production of smaller – more compact products, changes in design ergonomics, a rise in combination products and increased regulatory rules.
Build to Print Partner
Circuit Check partners with our customers for build to print racks including a detailed review and update of the customer’s documentation. We will also design and fabricate, self-test fixtures including the necessary software to allow for verification of proper test system operation.
Verification and Validation Testing
We provide end to end electrical design, software development and verification of each test system we build.
Quality, Reliability & Safety
Quality, reliability, and safety of your test systems is our top priority. Circuit Check projects include specification development following an ISO 9001 compliant design process that defines intended uses, design requirements, and the overall design plan for the test system. Once approved, the system is then designed and built to meet the documented requirements. Finally, the completed system is verified and validated against original requirements to ensure all design requirements and
intended uses are satisfied. This disciplined process provides documented traceability from requirement-to-result.
Accuracy and Performance
Circuit Check’s test systems for medical device test are based upon PXI modular hardware, user configurable modules and high-level user friendly test management software. Test stations can be deployed with board/product functional, RF and flash programming modalities. Once configured with measurement hardware, Circuit Check can include all the tools needed to support the software development lifecycle, including requirements management, code analysis and traceability, and unit tests. These deliverables can be used as a component to satisfy risk assessment and mitigation strategies outlined internally.
Design Services
Circuit Check’s Test System Engineering team provides full turnkey automated medical device testing solutions for electronic and RF / Wireless products. Our Test System Engineering team provides design for testability (DFT) consulting, requirements specification development, design, fabrication, system integration, installation, startup support, and sustaining services. Our experienced project managers, engineers, and technical staff work directly with our customers to ensure a successful project. A dedicated project manager is assigned to each project to ensure on-time, fast-turn and on-budget deliveries.
Documentation
Circuit Check specializes in reviewing documentation packages of existing systems and will provide updates for release to our customer’s document control center.
Capabilities
- Infusion Systems
- Imaging Systems
- Surgical Instruments
- Centrifuge Systems
- Ventilators
- Mixing and Weighing
- Pump Controllers
- Implantable Pacemaker Pulse-Generators