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
FDA appreciates product firms for non-violation of its rules and regulations and continues to be in contact with firms d
As we all are aware, the FDA declared a healthcare emergency that calls for Emergency Use Authorization of medical devic
EU MDD to MDR – A major change Medical Device Directive (MDD) which is in action now and will shortly be superse
Importance of remote monitoring devices during COVID19 pandemic. Given that these devices allow patients to timely get t
AI/ML changing the medical device industry Artificial Intelligence/Machine Learning based Software has revolutionized th
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
Learn about the importance of Quality Objectives (QO).
A 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe.
In recent times, there has been a growing concern related to the safety of breast implants.
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.
Medical Devices Advisory Committee consists of 18 panels with a maximum of 159 standing members.
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.
On April 16, 2019, manufacturers of surgical mesh were ordered to stop selling their products.