IVD, which stands for In Vitro Diagnostics, refers to tests done on samples such as blood or tissue that have been taken from the human body. These are the medical tests that doctors use to detect diseases, monitor treatments, or check overall health. Think of it like having a very advanced laboratory test tube where medical professionals can examine samples outside the body to get important health information. This term is commonly used in medical device companies, clinical laboratories, and healthcare facilities. You might also see it referred to as "laboratory diagnostics" or "clinical diagnostics."
Led quality control team for IVD product development
Managed regulatory compliance for In Vitro Diagnostic devices
Developed new IVD testing protocols for blood analysis
Supervised manufacturing of In-Vitro Diagnostics equipment
Typical job title: "IVD Professionals"
Also try searching for:
Q: How would you manage a new IVD product development from concept to market?
Expected Answer: Should demonstrate understanding of the entire product lifecycle, including design planning, regulatory requirements, clinical trials, quality control, and market launch strategies. Should mention FDA/CE mark requirements and risk management.
Q: What experience do you have with IVD regulatory submissions?
Expected Answer: Should explain experience with FDA 510(k), CE marking, or similar regulatory processes. Should understand documentation requirements and quality management systems.
Q: What quality control measures are important in IVD manufacturing?
Expected Answer: Should discuss quality control procedures, testing protocols, documentation requirements, and understanding of Good Manufacturing Practices (GMP) specific to medical devices.
Q: Explain your experience with IVD validation protocols.
Expected Answer: Should describe experience with test validation, documentation procedures, and understanding of accuracy, precision, and reliability requirements in diagnostic testing.
Q: What do you understand about IVD and its importance in healthcare?
Expected Answer: Should demonstrate basic understanding of in vitro diagnostics, their role in medical diagnosis, and awareness of different types of diagnostic tests.
Q: What safety considerations are important when handling diagnostic samples?
Expected Answer: Should show knowledge of basic laboratory safety procedures, proper sample handling, and awareness of contamination risks.