Calibration Of Medical Equipment Policy

The procedure that is used to inspect measure and test equipment should be traceable to national or international standards.

Calibration of medical equipment policy.

The medicines healthcare products regulatory agency mhra requirements state that healthcare organisations are responsible for ensuring their medical. Over the years the medical equipment policy and guidelines have been reviewed to update equipment specifications so as to conform to. With over 30 years experience in the design manufacturing and testing of medical test equipment we understand the urgency in calibrating medical test equipment quickly as well as to. The accuracy provided by such medical equipment was crucial to the overall output with respect to both quality and profitability.

We have decades of experience managing calibration programs in. Regular calibration was required to receive necessary certifications and licenses from regulatory authorities he said. In a nutshell fda guidelines for calibration of a medical device require the following. Calibrationhouse is able to calibrate your medical test equipment with a 3 day turnaround or visit you on site to reduce the downtime of your critical equipment.

Equipment calibration must be carried out routinely as per the company s written directions. Calibration of medical devices and manufacturing equipment needs to be performed on a routine basis by trained and certified professionals. Accredited calibration lab the calibration laboratory must be iso 9001 2008 accredited or be the original equipment manufacturer. The committee produced the first national medical equipment policy in 1991 which assisted both government and non government agencies to rationalize procurement and management of medical equipment.

Have confidence in knowing your medical equipment is functioning well and giving the accurate results needed at a time that suits you with our onsite medical calibration and testing service. A top priority for medical device manufacturers is the health and safety of patients and the accuracy and precision of the instruments used in production is of the utmost importance. Consider contracting the services of an approved biomedical engineering company to assist with equipment testing and maintenance. Medical equipment management 6 ensure that qualified personnel inspect test and maintain all medical equipment diagnostic therapeutic life support and monitoring.

Comprehensive equipment list to pass the iso audit the company must demonstrate that it has a comprehensive equipment list with controls in place for additions subtractions and custodianship of equipment. Medical equipment management plan cross reference. Medical equipment calibration calibration and asset management for medical device manufacturers. Environment of care policy no.