Manufacturers can spend years (not to mention a lot of money) to get clearance for their devices from regulatory agencies. But regulatory compliance doesn’t stop there. It’s an ongoing process that concerns all parties that are actively involved in the device life cycle: manufacturers, resellers, users, and biomedical equipment service and repair companies like US Medical Systems.

Regulatory compliance is ubiquitous. Rules and regulations change, new guidelines are published, and alerts and bulletins are sent out regularly. Being informed and keeping everyone updated are two of the fundamental aspects of staying compliant. When critical information is promptly received, processed, and distributed to everyone in the process, the required procedures or corrective actions will be performed without delay and in accordance with the rules.

Device data and relevant service events must be recorded. This allows them to be easily traced and quickly reported when needed. An efficient recordkeeping and tracking system that allows immediate access to essential information is key to ensuring that installed and serviced equipment is both accounted for and kept in conformity with the current requirements.

Our human nature means we’re predisposed to error. By anticipating these errors and responding to them, manufacturers can create processes to avoid these situations. In the healthcare industry, the majority of stringent regulations arise from practical experiences such as adverse events. The subsequent risk management is guided by the “do no harm” approach. There’s a substantial reason behind every rule. That’s why continuous education and training of service staff is so important. It’s equally important to develop policies and procedures detailing medical equipment management, service, and repair. These procedures address such important issues as inventory keeping, preventive maintenance, responding to errors and undesirable events, and quality control.

Staying up-to-date with regulatory requirements that come from different bodies can be quite challenging. US Medical Systems has the necessary tools to help you along the way. We have comprehensive tracking and reporting systems for your medical equipment. We provide you with the required quality control documentation as part of our biomedical equipment service and repair programs. Contact us at our Fort Mill, SC office and learn how we can help you with the critical task of keeping your medical devices compliant.