ISO 13485

Medical devices

13485 Medical Device

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 manufacture is held to stringent regulatory requirements. ISO 13485, Medical devices Quality management systems Requirements for regulatory purposes is a standard which 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. PlasticsOne has a strong commitment to quality. This commitment is seen, in part, by the ISO 13485:2016 Certification held since 2013. To obtain and keep this certification, annual surveillance and three-year recertification audits must be passed.