A Guide to Starting a Pacemaker Manufacturing Business in India
A pacemaker is a small, implanted device used to treat heart rhythm disorders (arrhythmias). Thus, a pacemaker has a considerable impact in the cardiovascular field of medicine. Starting a pacemaker manufacturing business in India is a highly lucrative opportunity. It...
A Guide to Starting a Catheter Manufacturing Business in India
India’s catheter manufacturing business market shows strong potential. It is driven by rising demand for vascular access and urinary catheters and government incentives for medical devices. India currently imports a significant share of catheters. Hence, local...
Mistakes in FDA Device Approval Submissions & How to Avoid Them
To launch your medical device in US, you will require FDA medical device approval. Broadly classified there are three types of FDA regulatory pathways, namely 510(k), De Novo, PMA, for FDA medical device approval. It is important to choose the correct regulatory...
Differences Between Substantial Equivalence and Predicate Device
Identifying the correct predicate device is the first critical step in US FDA 510(k) submission. The FDA authorities evaluate whether your device is substantially equivalent to the predicate device you have mentioned in the application. If it is equivalent, then your...