Conformity, accuracy, and precision are crucial for components of medical devices. Whether or not the final products will have a direct impact on a person’s health, they will eventually have some impact in the end. As a result, the standards for medical device manufacturing are incredibly high.
The medical device manufacturing industry is responsible for developing and supplying a wide range of products. Nearly all of these end up diagnosing or treating illnesses, as well as improving and maintaining the health of patients either directly or indirectly.
The International Organization for Standardization, or ISO, is responsible for making nearly all of the various standards that are used when manufacturing medical devices. The most common one, ISO 9001, sets general, non-industry specific standards for quality management systems. This type of certification helps to keep costs low, improve accountability, and simplify the journey to regulatory compliance.
The ISO has many other certifications that are for specific applications, as well as a general one for the medical industry in particular. ISO 13485 expands on the ISO 9001 standards, refining them for medical device manufacturing, while improving overall quality control, traceability, process validation, and risk management in a way that benefits the industry. ISO 13485 is necessary for critical devices and medical devices that will directly be used to impact a patient’s health.
A manufactured part’s precision and accuracy are highly dependent on the quality management systems in place as well as the quality of the equipment used to fabricate the part. The tight tolerances and intricate geometries that are common in medical device components require quality processes that can only be achieved through CNC machining and precision machining services. Equipment that is maintained, regularly inspected according to the quality management system, and carefully monitored during the manufacturing process, is much more likely to produce high quality and tight tolerance results, consistently and accurately.
Looking for a precision manufacturer for the medical industry?
Small Parts Machining is an ISO 9001 certified manufacturer of precision machined medical components, as well as parts for many other industries. To learn more about what we can do for you in the medical industry, contact us today!