Answered September 8th, 2009 by Expert:
I must admit to having a bias, but, at a minimum, I would ensure that the company has appropriate certification. Hypertronics is certified to ISO 13485, which sets a standard guideline.
ISO 13485 is designed to produce a management system that facilitates compliance to customer requirements with an emphasis on meeting regulatory and risk management requirements and maintaining effective processes, namely the processes specific to the safe design, manufacture and distribution of medical devices. It’s important to note that being certified to ISO13485 does not fulfil regulatory requirements, but it does help to align an organisation’s management system with many regulatory schemes around the world including US FDA’s Quality System Regulation (QSR).