Role of Qualification and Validation in Medical Device Industry: A Study

Rakesh Kumar*, Santosh Kumar**
* Department of Mechanical Engineering, Chandigarh University, Mohali, Punjab, India.
** Department of Mechanical Engineering, Chandigarh Group of Colleges Landran, Mohali, Punjab, India.
Periodicity:November - January'2022


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.


Installation Qualification, Operational Qualification, Performance Qualification, Validation, Procedure, Evidence, Medical Devices, Medical Device Industry, Orthopedic Implants.

How to Cite this Article?

Kumar, R., and Kumar, S. (2022). Role of Qualification and Validation in Medical Device Industry: A Study. i-manager’s Journal on Future Engineering & Technology, 17(2), 37-44.


[1]. Department of Health and Human Services. (1996). Federal Register. Office of the Federal Register, National Archives and Records Administration, 61(195), 52602-52662.
[2]. Bureau of Indian Standard. (2018). Implants for surgery, Cleanliness of orthopedic implants, General requirements (ISO 19227:2018), New Delhi, India.
[3]. WHO. (n.d.). Equipment and its Qualification. Rutendo Kuwana Technical Officer, WHO, Geneva.
[4]. Guidance for Industry. (2009), Process Validation: General Principles and Practices. U.S Food and Drug Administration, Washington, 1-19.
[5]. Chapman, K. G. (1991). A history of validation in the united states. I. Pharmaceutical technology, 15(10).
[6]. Garino, J. P., & Willmann, G. (Eds.). (2002). Bioceramics in Joint Arthroplasty: Proceedings. Georg Thieme Verlag.
[7]. Walsh, K. E., Cutrona, S. L., Foy, S., Baker, M. A., Forrow, S., Shoaibi, A., ... & Andrade, S. (2013). Validation of anaphylaxis in the Food and Drug Administration's Mini‐Sentinel. Pharmacoepidemiology and Drug Safety, 22(11), 1205-1213.
[8]. Jindal, D., Kaur, H., Patil, R. K., & Patil, H. C. (2020). Validation–In pharmaceutical industry: Equipment validation: A brief review. Adesh University Journal of Medical Sciences & Research, 2(2), 94-98.
[9]. Todde, S., Peitl, P. K., Elsinga, P., Koziorowski, J., Ferrari, V., Ocak, E. M., ... & Behe, M. (2017). Guidance on validation and qualification of processes and operations involving radiopharmaceuticals. EJNMMI Radiopharmacy and Chemistry, 2(1), 1-29.
[10]. Mantry, S., Ramya, L., & Kumar. S., A. (2014). An overview: Pharmaceutical validation. International Journal of Innovative Pharmaceutical Sciences and Research, 2(10), 2476-2497.
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