Test Apparatus and Fixture Design A high-quality product design should only transfer to production when the proper tools and measurement techniques are set in place to verify critical quality attributes are maintained. Furthermore, many industries are operating within an ISO 9001 or ISO 13485 quality management system that requires strict controls for transfer and production controls.
Mehor Solutions can help you with your design transfer by: ♦ Identifying critical quality attributes of RF design, antennas, cables, and attachments, ♦ Production tolerances that support yield and end user performance, ♦ Design, development, and fabrication of manual or automated test fixtures powered by LabView software, network/spectrum analyzers, phantoms, DAQs, and database repositories, ♦ Create solid files and technical drawings using SOLIDWORKS CAD software, ♦ Writing Installation Qualification/Operation Qualification/Performance Qualification procedures that support installation within your quality management system.
Risk Management
Risk management for medical devices is outlined by ISO 14971 and provides a framework for how a business may identify and control risks. Risks may arise from not only the intended application of the device, but also from failures of the device and foreseeable misuse of the device. Regardless of the complexity of the device, the nature of the industry has been towards complete integration of the product design by tapping on related standards to support. The following facets should be part of a robust risk management project effort: use related errors (user), design failure modes and effects (design), and process failure modes and effects (manufacturing). In addition, the standard identifies that risk management must be integrated with other business units. In doing so, a healthy risk program should have mechanisms to incorporate feedback from post market surveillance, complaints, non-conformances in manufacturing, and service/repairs. The expectation of a modern risk management program is that it is updated regularly and reviewed for continued acceptability.
Regulatory Compliance
FDA Submissions
SAR Test Coordination
Safety Test Planning
Efficacy Test Planning
FCC Submissions
EMI/EMC Test Coordination
Compliant Test coordination
Wireless Coexistence Testing for Medical Devices
Wireless coexistence considers how your device operates (or if it may be susceptible) and the various devices that could impede or harm your device, and vice versa. It uses a combination of risk management and product testing that is described in Association for the Advancement of Medical Instrumentation (AAMI) TIR 69 ʹ Risk Management of Radio-frequency Wireless Coexistence for Medical Devices and Systems and American National Standards Institute (ANSI) C63.27: Standard for Evaluation of Wireless Coexistence. This testing is not always straightforward and may require a modified test apparatus to monitor your device or the opposing electronic equipment.
Intellectual Property Protection
Providing technical content and writing and communicating with your Intellectual Property Lawyers in support of patent applications.