Because we manufacture medical devices and surgical instruments, Hammill works under more stringent rules than other types of manufacturing operations. The quality standards we uphold are designed to ensure proper manufacturing as well as to meet standards designated by industry and federal regulations. The main accreditations for medical device companies are set by the U.S. Food and Drug Administration and the ISO. Meeting the requirements set forth by these organizations shows the company’s commitment to optimal manufacturing processes. The basics of the regulations and standards are as follows:
- The FDA requires all businesses that produce or distribute medical devices in the U.S. to be registered. This establishment registration is designed to get safe and effective medical devices to market quickly as well as ensuring that current devices remain safe and effective. Devices are subject to such areas as premarket notification and approval, medical device labeling, quality system regulation, and post-market studies and tracking.
- The leading standards organization ISO develops global guidelines for manufacturers to follow to ensure that quality standards are being met. For medical device manufacturers, ISO 13485 is the highest quality management system standard. Once certified by a third party, a medical device company is proven to consistently meet the requirements for regulatory purposes.
How does Hammill Medical ensure safety within our organization and products? With safety training, good manufacturing practices, and following the mandates set forth by these organizations! We are registered with the FDA as a contract manufacturer of medical devices and have recently received our recertification registration for ISO 13485 accreditation. These requirements are in place to keep businesses adhering to best practices. Being aware of regulations—and abiding by them—keeps our products, and those using them, safe year round.