Compliance with US FDA regulations is mandatory for marketing and distributing medical devices in the U.S. The US FDA 510(k) approval process authorizes the marketing of medical devices in the US. Timing, completion, and accuracy are of paramount...
Wearable defibrillators are non-invasive lifesaving medical devices. Hence, their manufacturing process is strictly regulated. In this blog, we have discussed the wearable defibrillator manufacturing process. Additionally, we have highlighted the regulations for...
Currently, India’s medical device market heavily relies on imports. UK is among the top countries from which India imports medical devices. The demand for UK-imported medical devices is strong and projected to grow. Furthermore, the India-UK Free Trade Agreement...
Quality assurance (QA) has a pivotal role in ensuring the safety, efficacy, and reliability of medical devices throughout their entire lifecycle. It covers conception and development to manufacturing, distribution, and post-market surveillance of medical devices....
Quality cannot be compromised in medical device production. Maintaining consistent and high product quality is of paramount importance in the medical device industry. Common quality challenges in the medical device industry are production, technical, regulatory, and...
India is aiming to reduce its import dependency and boost domestic medical device manufacturing. However, a major supply of India’s medical device requirements comes from China. India is still heavily import dependant for fulfilling its medical device demands....