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 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. Plastics One has a strong commitment to quality.
PlasticsOne proudly adheres to quality ISO management standards, Lean Six Sigma and cleanroom ISO Class 7 and Class 8.