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Compliance Engineering Reference Guide Index

QuadTech Inc.

5 Clock Tower Pl., 210 E.
Maynard, MA 01754 USA
Tel: 800-253-1230
Fax: 978-461-4295

Web: http://www.quadtech.com
E-mail: sales@quadtech.com

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Click below for the latest QuadTech Inc. Press Release

Quadtech Launches New Power Source Product Line

Electrical Safety Test Solutions
QuadTech's Sentinel System is a fully automated Electrical Safety Test solution designed specifically for Medical Device Manufacturers (MDM). The Sentinel System helps MDMs improve the overall efficiency of manufacturing processes because it enables a dramatic reduction in the number of test instruments, processes and operator involvement necessary for testing medical devices, and, allows for global collaboration, lowered production costs and electronic data collection.

The Sentinel System is scalable, flexible and completes electrical safety testing to IEC60601-1 and IEC60601-2-49, while improving compliance with QSR ISO13485 and FDA's 21 CFR 820. It accurately controls line voltage to the Device Under Test (DUT) while performing hipot, leakage current and functional tests, and, scans patient connections for leakage current without powering down the DUT.

After review and consultation with a QuadTech engineer, solutions are built to customer specifications.

Automated Testing
QuadTech solutions are driven by QuadTech's CaptivATE Automation Software which automatically downloads test setups, creates test sequences, conducts required measurements, and outputs the test results to a print file and/or a database for later printing, viewing, trending and analysis. Test data can be saved to a csv file for easy import from CaptivATE into any enterprise system, such as a Manufacturing Execution System (MES).

Medical Device Industry Experts
QuadTech has a dedicated team of professionals who focus exclusively on the needs of medical device manufacturers and possess in-depth knowledge of medical applications. Medical team members apply their industry knowledge, understanding of standards compliance requirements and vision of future industry trends to understand a manufacturer's current testing process and recommend solutions to correct compliance issues.

QuadTech also partners with UL to support educational requirements for medical device manufacturers, offering public and private seminars addressing various safety regulations.

QuadTech, Inc.
5 Clock Tower Place, 210 East
Maynard, Massachusetts 01754
USA
Tel: +1 800 253 1230 (USA Toll Free)
Tel: +1 978 461 2100
Fax: +1 978 461 4295
Web: www.quadtech.com
Email: sales@quadtech.com

Categories this company is listed under in the Compliance Engineering Reference Guide: