Medical equipment calibration calibration and asset management for medical device manufacturers.
Calibration of medical equipment policy.
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.
We have decades of experience managing calibration programs in.
Equipment calibration must be carried out routinely as per the company s written directions.
The procedure that is used to inspect measure and test equipment should be traceable to national or international standards.
In a nutshell fda guidelines for calibration of a medical device require the following.
Medical equipment management plan cross reference.
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.
Environment of care policy no.
Accredited calibration lab the calibration laboratory must be iso 9001 2008 accredited or be the original equipment manufacturer.
Calibration of medical devices and manufacturing equipment needs to be performed on a routine basis by trained and certified professionals.
If errors are noticed adjustments and repairs need to be made followed by re calibration to verify the accuracy of calibrated 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.
Regular calibration was required to receive necessary certifications and licenses from regulatory authorities he said.
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.
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.
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.
The accuracy provided by such medical equipment was crucial to the overall output with respect to both quality and profitability.
Medical equipment management 6 ensure that qualified personnel inspect test and maintain all medical equipment diagnostic therapeutic life support and monitoring.
