CTAP – a step towards acceleration of therapies for COVID 19 After the emergence of COVID 19, FDA began working wi
In an attempt to flatten the curve of COVID-19, many countries implemented lockdown policies. People are allowed to leav
Various benefits and flexibilities for Medical Device Manufacturers have been recently introduced. It’s impressive to
As we all are aware, the FDA declared a healthcare emergency that calls for Emergency Use Authorization of medical devic
Importance of remote monitoring devices during COVID19 pandemic. Given that these devices allow patients to timely get t
An eCopy is an electronic version of a medical device submission on a CD, DVD, or flash drive, and is accompanied by a p
As rightly said, “Perfection is not attainable, but if we chase perfection we can catch excellence.” The urge to cre
A 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe.
The Software Pre-Cert Program is a pathway is more visible than the current model to assess the safety and effectiveness
Patient inputs have always remained the core for healthcare systems, healthcare professionals and manufacturers.
Standards are considered as an integral part of the product design and development.
De Novo classification is not just a device reclassification process for medical devices but it is an application also.
Diagnosis plays a vital role in curing a disease.