Essenvia

#medtech #regulatoryaffairs professionals - how are you doing version control in eSTAR? (@US_FDAs new regulatory submission format) Any tips and tricks to share with the community?

Today we welcome Chris Shakarian to Essenvia as our VP of Marketing! Chris brings 20+ years of B2B SaaS marketing experience across many industries including healthcare & life sciences. Chris, we can't wait to make Essenvia a household name for #regulatoryaffairs in #medtech!

We're thrilled to welcome Driti Roy as our new VP of Regulatory Transformation and Customer Success. Driti is an experienced #regulatoryaffairs professional & prolific visionary in the space (the real deal!) - Driti, we can't wait to build the future of #medtech #rim with you 🚀

Hey #regulatoryaffairs pros - are you ready for @US_FDA's eStar in October? Hit the EASY button with Essenvia & get 100% acceptance: bit.ly/4220dWl

Hey #regulatoryaffairs professionals - are you ready for FDA's eStar? Coming to a #medtech device near you on October 1, 2023.

Congratulations @essenvia on this milestone! We are proud to lead this funding alongside @Wavemaker360. #enterprise40 #crossborder #innovation

We're thrilled to announce we just raised $4M in funding with @BGVcapital and @Wavemaker360 to help MedTech regulatory teams supercharge their regulatory submissions: tinyurl.com/2dumc7nm #MedicalDevices #regulatory #MEDTECH

Question Of The Week: For those who have ever submitted a #510kApplication: What is the most important piece of information you ever have found in the #FDADatabase and how did it help you gain #FDA clearance? Let's start a conversation by placing your answers in the comments!

Big Time Medical Investments #HHS and #DOS invest a combined $562 Million to increase #COVID-19 test manufacturing in an attempt to provide more testing options across the country. Mass Device has the scoop in their latest article found here: ow.ly/cPfU50Gxuuj

Question Of The Week To all our medical device industry professionals out there: What is ONE thing you would change about the regulatory submission process and why? Let’s get the conversation going in the comments! #regualtorysubmission #fda #mdr #medicaldevices #510k

How has COVID-19 impacted the future of medical devices? What types of trends should we expect throughout 2021 and beyond? The #IDC has you covered as they dive deep into these and other key questions pertaining to #MedicalDeviceTrends. ow.ly/mWCC50Gxs4Z #medicaldevices

Have you ever wondered what the difference between #FDACleared VS #FDAApproved means when it comes to #MedicalDevices? Don’t worry, we have you covered. Our latest post breaks it all down and gives you the knowledge you need to move forward with the FDA ow.ly/guUT50GxqVk

In Sept alone, the #FDA added 14 new #GuidanceDocuments: ow.ly/Ntox50Gti4c This is just another reason why manually compiling your #510k isn’t going to work. It’s time to explore automation tools to optimize your #RegulatorySubmission process. essenvia.com/510k

Question Of The Week! If you work in the medical device industry, please tell us about a time when you made a huge mistake with a regulatory submission, how you fixed it, and the lesson you learned! #regulatorysubmission #FDA #MDR #510k #CE #techfile #regulatoryoperations

Planning to submit a #TechnicalDocumentation for #certification soon? We suggest checking out this Best Practice Guidelines eBook created by BSI! It walks you through each crucial step including: What To Include Format To Use How To Submit and more! ow.ly/mgSf50GtgTu

The 5 most important elements of your #RegulatoryStrategy are: FDA Product Code Reg. Number Indications For Use Test Requirements Guidance Documents All of this valuable information is found in the #FDA’s #510(k) database. Click here to learn more: ow.ly/WZh450Gtf9k

Question Of The Week Which phase of a medical device’s regulatory lifecycle is the most challenging to manage and why do you feel that way? Please leave your answer in the comments! #regulatorysubmission #MDRsubmission #510kapplication #FDA

Reason #1: You Need To Have The Most Up To Date #FDA Documents Read the additional four key reasons why you can no longer afford to submit your #510kApplication without expert guidance. #fdaclearance #regulatorysubmissions #mdr ow.ly/dC2I50GpAf9

You can no longer afford NOT to automate your #RegulatorySubmission process. Between the thousands of pages of documents, dozens of collaborators, and ever-changing guidance documents, failing to optimize will result in rejection. #510 #MDR #FDA essenvia.com

Last month, the #FDA released a brand new resource making it easier to find approved medical devices that incorporate #ArtificialIntelligence. The list currently includes 343 devices, with more being added every month. Read More:  ow.ly/Tn7Q50Gpyi3 #fdaclearance