As outlined in a recent report by the Global Health Technologies Coalition, the regulatory environment for diagnostics in many low- and middle-income countries is lacking, allowing sub-standard products to reach the market with potentially devastating impacts on healthcare and patients' lives. WHO prequalification requirements for diagnostics are currently still limited only to diagnostics test for HIV, malaria, and tuberculosis.
In the absence of clearly defined regulations for poverty-related disease diagnostics in many markets the integration of quality control and quality management in the development of diagnostic tests is of utmost importance.
At Mondial Diagnostics quality management is a key element in the entire process from development of a new diagnostic test until it reaches the patient. We integrate quality control and quality management in each new test we develop as well as for each biomaterial, and transfer this to our manufacturing partners. Quality control and quality management are key elements of the Knowledge and Technology Transfer Program through which we help our partners develop their capacity to manufacture rapid diagnostics for local/regional use.