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....
Cleanrooms are specialized and controlled environments vital for the manufacturing and packaging of medical devices. They are designed to reduce airborne particles, microbes, and other contaminants that could compromise device quality, efficacy, and safety. This...
Proper sterilization of medical devices is a necessity to reduce chances of infection caused by these devices. In this blog, we have discussed ETO sterilization for medical devices, which is a commonly used medical device sterilization method. What is medical device...
Medical device product recalls are part of regulatory oversight for ensuring the best quality devices are available in the market. Getting notified by regulatory authorities for product recall will tarnish the medical device manufacturer’s image. Hence, we have...