Calibration Of Medical Equipment Policy

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.

Calibration of medical equipment policy.

Are required to maintain current test eq uipment calibration certificates for all test equipment used in the performance of both scheduled maintenance and repair services of medical equipment. In a nutshell fda guidelines for calibration of a medical device require the following. Accredited calibration lab the calibration laboratory must be iso 9001 2008 accredited or be the original equipment manufacturer. Regular calibration was required to receive necessary certifications and licenses from regulatory authorities he said.

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. Environment of care policy no. Over the years the medical equipment policy and guidelines have been reviewed to update equipment specifications so as to conform to. Consider contracting the services of an approved biomedical engineering company to assist with equipment testing and maintenance.

We have decades of experience managing calibration programs in. At present nabl has accredited about 5 000 laboratories in india relia said. Medical equipment management 6 ensure that qualified personnel inspect test and maintain all medical equipment diagnostic therapeutic life support and monitoring. The procedure that is used to inspect measure and test equipment should be traceable to national or international standards.

Medical equipment calibration calibration and asset management for medical device manufacturers. If errors are noticed adjustments and repairs need to be made followed by re calibration to verify the accuracy of calibrated equipment. 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. Equipment calibration must be carried out routinely as per the company s written directions.

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. 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. The medicines healthcare products regulatory agency mhra requirements state that healthcare organisations are responsible for ensuring their medical. Medical equipment management plan cross reference.