Regulatory Compliance
● Medical device recall information is collected and analyzed, and appropriate follow-up is conducted. ● Medical device tracking reports acquisition of tracked devices to OEM. ● Device-incident reporting includes investigation of every equipment-related death or serious injury. ● Upcoming regulations are continually watched. ● OSHA regulations compliance is ensured for blood-borne pathogens and hazardous chemicals.
Staff Management and Quality Improvement
● Staff qualifications and training includes clear requirements for background, initial, and ongoing training. ● Customer surveys are conducted for external and internal customers. ● The QA program is being revised constantly as new science of HTM emerges.