Quality Policy
We the employees of PRII are dedicated to improving patient quality of life by designing the next-generation of innovative and advanced medical devices. Safety, effectiveness and continuous improvement of our products is our focus. Exceeding customer expectations is our driving force.
Quality Systems
Quality Systems are essential to successful design, development and manufacture of medical devices. PRII has implemented and maintains a quality system compliant with the requirements of ISO 13485:2003, ISO 14971:2007 and federal regulation 21CFR Part 820.
The philosophy at PRII is to design quality, safety, and effectiveness into the device.
A seven-phase development process is followed and throughout each phase, the focus is on the assurance of quality and the prevention of defects and errors. To facilitate this, emphasis is placed on clarification of user needs and customer requirements; planning; allocation of appropriate resources for execution; and evaluation and verification of results.
