As rightly said, “Perfection is not attainable, but if we chase perfection we can catch excellence.” The urge to cre
Clinical trials being a resource, cost, and time extensive process, identifying the right location for a clinical trial
Getting an IVD product to the market is a cumbersome task and takes several months to over a year to finally get everyth
Everyone knows that the advent of MDR was postponed, and the new regulation shall be in full force from May 26, 2021. As
“O lost, and by the wind grieved, ghost, come back again.” as rightly said by Thomas Wolfe; the globe faces a deadly
The first step towards bringing your product to the market is understanding which center at the FDA shall regulate your
EU Notified Bodies designated under the EU MDR (2017/745) Sl.No. Notified Body Name Notified Body Location Notified Body
Software Development Life Cycle (SDLC) is the most important element of a Software as a Medical Device (SaMD)Quality Man
Here are the most common documentation problems that Elexes has helped its Clients with: Faulty Document ControlIt
The road to certification w.r.t. ISO 13485 and MDSAP is certainly a long one, but with systematic planning and execution
“Continuous improvement is better than delayed perfection” – As rightly said by Mark Twain. Design Review ensu
When crafting a budget for your medical device development and launch, it is important to know the primary sources of mo
Testing is the most important element of any medical device development. Comprehensive and successful testing certainly
FDA Emergency Use Authorization (EUA) program is a great way to help out in an emergency situation, whether it is for di
The new Medical Device Regulation has been postponed by a year, however, the regulation is still coming and all medical
A lot of companies are being asked by their government to make PPE to help during COVID crisis, and many are choosing to
When companies are looking to get their product to the market, they certainly want to get it there as soon as possible.
Why was EUA started? The Emergency Use Authorization (EUA) program was first established in 2004 and has a well-defined
FDA ratifies more than 200 petitions annually and only a few are successfully filed in the system. Anyone can file
FDA has the authority to regulate categories of cosmetics, drugs, devices, biologics, and foods. However, during the pro
CTAP – a step towards acceleration of therapies for COVID 19 After the emergence of COVID 19, FDA began working wi