Every user, distributor, or prescriber of any type of medical device wants confidence that the device will perform as intended. Part of that confidence comes from the knowledge that the medical device manufacturer is held to stringent regulatory requirements. ISO 13485, Medical devices – Quality management systems – Requirements for regulatory purposes is a standard that sets specific requirements for quality management systems to ensure organizations meet customer and regulatory needs through basic design and development, production, storage, distribution, and installation criteria. P1 Technologies has a strong commitment to quality. This commitment is seen, in part, by the ISO 13485:2016Certification held since 2013. To obtain and keep this certification, annual surveillance, and three-year recertification audits must be passed.
