ISO 13485 injection molding is a highly rigorous external auditing process used to ensure producers of medical device components strictly and consistently follow and meet their clients’ specific requirements. Patient health and safety are largely dependant on a molder’s credentials. ISO 13485 certifies that this manufacturer has a well-established Quality Management system to ensure product quality, safety, and compliance with regulatory requirements, including good documentation processes (GDP) and good manufacturing practices (GMP). PreciKam spends thousands of hours on training, internal as well as external audits and procedures every year to manage the risk of defects or failures in a final product. Before choosing a contract manufacturer, make sure you ask them how much they invest in quality and safety!