July 9, 2009
Originally Published MPMN July 2009
Laser-cutting efficiency software
Designed to find hidden laser-cutting capacity, a software program incorporates lean manufacturing methods to increase throughput and material utilization. Using a database of all active part files, Scheduler software prioritizes nesting by part due date and automatically nests parts for optimum material usage. Users can enter order requirements, part numbers, due dates, and quantities to generate a job schedule in a calendar format. The software also identifies parts for which on-time delivery may be a problem, allowing for schedule adjustments in order to meet delivery deadlines. A color-coding feature groups jobs with similar lens and nozzle setups to facilitate unattended operation and maximize productivity of laser-cutting systems. An integrated material-handling system automatically tracks material inventory.
Device code analysis
To help OEMs determine the functionality of their medical device code-base and whether their device software is ready for release, a software supplier offers customized static and run-time analysis tools. The company’s Code Hardening service includes a series of code walkthroughs by senior systems architects who are specifically trained in medical device code-base technology. Additionally, quality assurance (QA) engineers run a battery of tests from a library of prewritten scripts and other QA automation tools. The service provider gives the OEM a detailed report that identifies areas of the source code that are problematic, including an explanation of why those parts of the code are causing problems. It also rates the code problems by severity and offers to address the technical issues for the OEM.
Full Spectrum Software
A compliance-management software program includes document control, auditing, and corrective and preventive action (CAPA) tracking and management. Q-Pulse software is designed to help ensure compliance with ISO 13485, FDA regulations, and European directives. By enabling integration of specific compliance work flows, the software helps manufacturers improve their regulatory compliance. The Windows-based program also features such integrated tools as supplier review and approval, asset and workload management, and training and competence tracking.
Enabling more-efficient interdepartment communication, a business process-management software platform is designed to help medical device OEMs get their products to market faster without sacrificing regulatory compliance. MasterControl MD allows departments to collaborate on critical documents and processes to speed up the development cycle. The program also helps manufacturers stay compliant with 21 CFR Part 820 and ISO 13485 standards. Design history files and technical dossiers can be easily organized using the program, and the Web-based platform enables electronic collaboration and automated approval from the design phase through manufacturing. The integrated enterprise program also features built-in analysis tools and scheduled reports to track quality metrics and trends.
SALT LAKE CITY
Providing enterprise compliance- and quality-management software, a company offers a program for the efficient analyzing, reporting, and exporting of existing data. Because static reports are not always sufficient to accelerate decision making and effectively measure performance, SmartPulse software uses prebuilt data cubes that are generated from transactional data to enhance the user’s ability to quickly analyze operations and business conditions. Features of the program include simple data navigation, calculation and visualization tools, and dashboards consisting of one or more worksheets. These tools enable better communication and coordination among business departments, such as enabling departments to respond to change within the organization more quickly. Using the program to improve fact-based decision making can help OEMs to eliminate guesswork, understand why certain design or process decisions were made, and improve overall performance.
For additional software suppliers, go to the Buyers Guide tab at devicelink.com/mpmn and click on Manufacturing Equipment and Software
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