Medical Device Testing Systems and Medical Safety Analyzer Solutions

QuadTech offers a number of solutions to meet the demands of medical device testing. From a single medical device safety tester (medical safety analyzer) to a complete medical device safety testing solution - QuadTech's Medical Safety Analyzer- Sentinel System:

Flexible, scalable medical devices testing solutions built to customer specification
Perform electrical safety testing and continuity measurements
IEC 60601-1 and 60601-2 testing
Using CaptivATE, automate testing and data collection, efficiently perform data and statistical analysis for corrective and 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 test equipment and improving operator efficiency

Use the chart below to help you find the medical devices testing solution that will solve your testing challenges.

Simple Testing <============================> Complex Testing

0-1 Patient Connections <=================> up to 16 Patient Connections


Test	Sentinel I	Sentinel II	Sentinel III
Ground Bond	√	√	√
AC Hipot up to 5kVac	√	√	√
DC Hipot up to 6kVdc	√	√	√
Insulation Resistance	√	√	√
Earth Leakage	√	√	√
Enclosure Leakage	√	√	√
Patient Leakage - 1 B-Type	√	√	√
Patient Auxiliary Leakage	√	√	√
Programmable AC Source		√	√
Mains to AP Dielectric Withstand			√
F-Type Leakage (110% Mains on Applied Part) - up to 16 points			√
110% Mains on SIP/SOP's			√

Read some of QuadTech's application notes highlighting Electrical Safety Testing and Medical Device Testing, or on IEC 60601-1!