15 April 2012

Heartsine Technologies

FDA regulations and audits causing administrative headaches? Not for Heartsine.


Heartsine Technologies manufacturer portable defibrillators and distribute them to a worldwide target market. Having roots that go back to the inventor of the portable defibrillator with the Mobile Coronary Care Unit set up by Prof. Frank Pantridge, they have a growing network of distributors and an even bigger list of customers.

In order to sell such devices in the US market, these devices and the administrative processes involved in manufacturing and shipping these portable defibrillators are audited by the FDA. The old system was clearly incapable of complying with the stringent rules as set by the FDA.

Gravity were tasked with creating systems that would gather end user warranty registration information and store it in a compliant manner, in accordance with rules as set by the FDA. It would also reduce the amount of labour required to manage the reseller network through centralisation. Our solution provided Heartsine staff with a centralised secure solution reducing downtime due to FDA audits to a minimum.

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