Glossary Term
A study that compares two groups of people: those with the disease or condition under study (cases) and a very similar group of people who do not have the disease or condition (controls). Researchers study the medical and lifestyle histories of the people in each group to learn what factors may be associated with the disease or condition. For example, one group may have been exposed to a particular substance that the other was not. Also called retrospective study.
Performance Metrics
Glossary Term
The proportion of all the observations that have been classified correctly by the diagnostic procedures in given population, or using some diagnostic test, or by some medical institution or professional.
Performance Metrics
Glossary Term
The international quality-management standard for medical device manufacturing. Certification does not certify individual products, but suppliers with ISO 13485-registered production generally support tender documentation more reliably.
Regulatory Definitions
Glossary Term
Any physical object that is useful for prevention, diagnosis, monitoring, or treatment of disease or other conditions.
Regulatory Definitions
Glossary Term
Programs of regular assessment of medical and nursing activities to evaluate the quality of medical care including all actions taken to ensure that standards and procedures are adhered to and that delivered products or services meet performance requirements.
Performance Metrics
