In this blog, we have highlighted the key differences between CE mark and FDA approval. Additionally, we have discussed which is easier to secure and the required timelines for approval. This blog will be especially helpful for those entering new international...
Given their important role in healthcare industry, in-vitro diagnostic devices (IVDs) have to be strictly regulated and monitored. CDSCO has formulated strict guidelines for IVDs in India. This apex regulatory body is aimed at enforcing these regulations to monitor...
With skilled professionals and strong academic and research infrastructure supporting innovation, Kerala’s medtech industry is rapidly growing. Additionally, the Kerala government is providing considerable support to the medical device industry. Withing 5 years,...
Hospital beds are specialized beds that are designed for use in healthcare facilities, like hospitals, clinics, and long-term care centres. Medical-surgical bed, hydraulic bed, manual bed, electric bed, bariatric bed, birthing bed, orthopedic traction bed, etc....
Medical devices design and development is an intricate procedure with multiple parameters to keep in mind. Moreover, medical devices are strictly regulated. Hence, regulatory compliance should be at the core of the design and development process. ISO 13485:2016...