QuadTech Medical Device Testing Division

The primary challenge facing electro-Medical Device Manufacturers (MDM) today is getting products to market quickly and efficiently while controlling costs and meeting regulatory compliance. Complexity of medical device testing, operational and process errors, manual test setups, maintaining operator safety, medical safety analyzer instruments, insulation resistance test instruments and hand-written test records are just a few of the factors contributing to this challenge.

QuadTech, an ISO 9001:2000 registered firm, is the only company providing scalable, off-the-shelf, fully automated medical device testing solutions designed specifically for Medical Device Manufacturers (MDM). Our solutions in medical device testing help to streamline customers' manufacturing processes while ensuring compliance with Quality Systems Regulations, Good Manufacturing Practices and to Regulatory Standards, such as IEC 60601-1 and 61010. Built to customer specifications, these medical device testing systems and medical safety analyzer instruments are scalable to meet current testing needs and expandable for future growth, minimizing future equipment and validation investments.

Enhanced Medical Device Testing

Automating the medical device testing process is a key driver for the future. It enables MDMs to collaborate on a global level, keep production costs down, collect data electronically, improve compliance with global regulatory requirements such as IEC 60601-1, and improve the overall efficiency of manufacturing processes.

Using QuadTech's CaptivATE software, medical devices testing data is electronically captured and can be shared across networks for viewing, regenerating test certificates and performing Statistical Process Control (SPC). CaptivATE far improves the medical devices testing of MDMs.

When a single electrical test equipment instrument, insulation resistance test instrument or medical safety analyzer does not satisfy your medical device testing needs, consider a complete solution - QuadTech's Sentinel System:

• Flexible, scalable medical devices testing solutions built to customer specification
• Perform electrical safety testing & continuity measurements
• Automate medical device testing, electrical safety testing and data collection, efficiently perform data & statistical analysis for corrective & preventative action
• Reduce operator involvement and eliminate operator error and judgment calls
• Improve compliance with QSR ISO 13485 & FDA's 21 CFR 820
• Improve lean manufacturing by consolidating multiple test processes, decreasing the number of pieces of medical test equipment & improving operator efficiency

QuadTech has a variety of solutions and medical electrical test equipment for testing medical implantable leads, cables and components such as ICD Leads, Pacemaker Leads, Neurostimulation Leads, Implantable Feedthroughs, EMC Filter Capacitors, and Headers. Our medical devices testing solutions and medical safety analyzer instruments consist of fixturing, software and instrumentation, and are designed to assist medical manufacturers with compliance with FDA and other regulatory agencies. QuadTech’s measurement capability include: Multipoint Hipot, Insulation Resistance, point-to-point 2 Wire and 4 Wire Low Resistance, end-to-end Continuity, Capacitance and ESR measurements.

QuadTech has significant experience with fixturing and testing implantable leads cables and components in medical devices testing. Whether at incoming inspection, assembly, or final test processes, QuadTech Multi-Point Test Systems provide an automated solution for performing Multipoint Hipot, Insulation Resistance testing, Isolation Testing, as well as point-to-point 2 Wire and 4 Wire Low Resistance Testing on these components by implementation of:

Hardware - Provides automated multi-point scanning for Hipot, Insulation Resistance, Isolation, 2-Wire, and 4-Wire Low Resistance Tests on the electrodes and conductors

Software - Controls the medical safety analyzer test process, collects the data from the test, generates test reports, provides SPC capability, MES Integration, and removes the Human Factor from the testing process

Fixturing - Custom designed medical safety analyzer test fixtures provide repeatable and reliable method for making contact to distal and proximal electrodes of Implantable Leads or other points of measurement

The result is a complete medical device testing solution that provides an efficient, reliable, and reproducible medical safety analyzer test system that ensures product compliance and quality while providing traceable test data.

Our medical devices testing solutions and medical safety analyzer solutions are supported by our Medical Division which is comprised of sales, engineering and customer support. This team has extensive knowledge and experience in all aspects of IEC 60601 and 61010, medical devices testing equipment manufacturing best practices and regulatory compliance standards. Our medical team works with each MDM customer to tailor a medical device testing solution to meet their specific requirements to help make them successful. QuadTech's equipment provides R&D, manufacturing, service and field testing of IEC60601-1 Class I, Class II and Internally Powered products in accordance with strict medical device standards. QuadTech also partners with Underwriters Laboratories (UL) to support educational requirements for medical device manufacturers, offering public and private seminars addressing various safety regulations.

The bottom line is this - At QuadTech, our mission is to "make our customers successful."