Validation and verification are procedures that ensure that
medical device
A medical device is any device intended to be used for medical purposes. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assura ...
s fulfil their intended purpose.
Validation or verification is generally needed when a health facility acquires a new device to perform
medical test
A medical test is a medical procedure performed to detect, diagnose, or monitor diseases, disease processes, susceptibility, or to determine a course of treatment. Medical tests such as, physical and visual exams, diagnostic imaging, genetic ...
s.
Validation or verification
The main difference between the two is that validation is focused on ensuring that the device meets the needs and requirements of its intended users and the intended use environment, whereas verification is focused on ensuring that the device meets its specified design requirements.
For instance, a regulatory agency (such as
CE or
FDA
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food ...
) may ensure that a product has been validated for general use before approval. An individual laboratory that introduces such an approved medical device may then not need to perform their own validation, but generally still need to perform verification to ensure that the device works correctly.
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Workflow
Standards
Standards for validation and verification of
medical laboratories
A medical laboratory or clinical laboratory is a laboratory where tests are conducted out on clinical specimens to obtain information about the health of a patient to aid in diagnosis, treatment, and prevention of disease. Clinical medical labor ...
are outlined in the international standard
ISO 15189
''ISO 15189 Medical laboratories — Requirements for quality and competence'' is an international standard that specifies the quality management system requirements particular to medical laboratories. The standard was developed by the Internatio ...
, in addition to national and regional regulations.
[
As per United States federal regulations, the following analytical tests need to be done by a medical laboratory that introduces a new testing device:
To establish a reference range, the ]Clinical and Laboratory Standards Institute
The Clinical and Laboratory Standards Institute (CLSI) is a volunteer-driven, membership-supported, not-for-profit, standards development organization. CLSI promotes the development and use of voluntary laboratory consensus standards and guidelin ...
(CLSI) recommends testing at least 120 patient samples. In contrast, for the verification of a reference range, it is recommended to use a total of 40 samples, 20 from healthy men and 20 from healthy women, and the results should be compared to the published reference range. The results should be evenly spread throughout the published reference range rather than clustered at one end. The published reference range can be accepted for use if 95% of the results fall within it. Otherwise, the laboratory needs to establish its own reference range.
See also
*Validation (drug manufacture)
The process of establishing documentary evidence demonstrating that a procedure, process, or activity carried out in testing and then production maintains the desired level of compliance at all stages. In the pharmaceutical industry, it is very i ...
References
{{reflist
Quality management
Product testing
Systems engineering