What is eSTAR? Starting October 1, 2023, all 510(k) submissions, unless exempt, are required to be electronically filed through eSTAR. This electronic system is specifically tailored as an interactive PDF document for assembling a comprehensive pre-market submission of medical devices intended for FDA 510(k) clearance within the United States. Additionally, eSTAR offers a resource for […]
A Guide to FDA eSTAR Submission Template Read More »
Removal of ‘Sell-off Date’ as One of the Major Benefits From EU MDR Transition Extension Removal of “sell-off date” can be considered as one of the benefits of EU MDR Transition Extension. To Elaborate More on This Benefit, Let us Just Understand What Is Sell-Off Date? Sell-Off Date means the last day of the Sell-Off
‘Sell-Off Dates’ Removal Finalised: Extension to EU MDR Transition Periods Read More »
Regulatory Strategist to Introduce Medical Device in Market Once medical device design and development is in place, it is very important for medical device manufacturers to introduce the device in maximum possible Market to sustain their financial goals For any medical device manufacturer, it is very challenging to meet Global regulatory requirement at a time.
A Guide to Effective Regulatory Strategies Read More »
Extension of EU MDR Transition The recent announcement of the EU MDR transition extension need not make you to procrastinate the actions to be taken to be EU MDR compliant as soon as possible if you wish to gain competitive advantage and enhanced market share in future. It is widely accepted fact that, delivering “preferred
Don’t procrastinate due to the EU MDR Transition extension : Results may be Costlier Read More »
