Role of qualification and validation in medical device industry: a study

Abstract

The need for orthopedic implants is increasing due to the rise in the number of accidents. As people begin to age, they begin to experience pain in their joints, bones, and wrists. If it is not managed with medication, an orthopedic implant may be deemed as the best solution. As per the Bureau of Indian Standard Research, the global market for orthopedic products in 2016 in US dollars was 4.20 billion. Industries seem to have an annual growth rate of 6.1 percent when compared with the previous year, which means the market is expected to reach 61.02 billion dollars by 2023. Therefore, the demand for orthopedic devices is significant and the quality of implants manufactured should be strictly controlled and checked for human health safety worldwide. Nowadays, the regulatory agencies also focus on every medical device manufacturing industry with highly stringent needs. Therefore, the knowledge of standards, validation, and differences between Good Manufacturing Practice (GMP) and Current Good Manufacturing Practice (CGMP) is highly important. Therefore, this paper focuses on the importance of validation in detail for the safety of patients.