CAPABILITIES & SERVICES
Hart Enterprises, Inc. has built its reputation on producing the highest quality medical devices and the best customer service available in the medical industry.
Maintaining this reputation is our first priority.
Three cardinal principles define our efforts.
We will provide a safe environment for our employees and the surrounding community. Each employee must be a part of this effort and is responsible to report any unsafe work condition immediately. If a job cannot be done safely it will not be done at all.
We recognize our responsibility to produce safe, effective medical devices. When producing product, or making decisions, each employee is directed to consider whether they would be willing to have the device they are producing used on themselves or their family. This is a real possibility.
We recognize that quality has a cost. A perfect medical device will not benefit anyone if it never reaches the user because it cannot be afforded. In design, manufacture and inspection we will strive to achieve the highest quality possible at an affordable cost.
In order to promote the above principles, we have created a Quality Management System which is intended to make the above principles a way of life at Hart Enterprises. In order to ensure the integrity of that system and promote acceptance of those guiding principles we have designed our Quality System to be in compliance with ISO 13485:2016 and 21 CFR 820 Quality System Regulation and hereby assert our commitment to maintain that system is compliance with these two standards that are universally recognized in our industry.