Essenvia

Essenvia is the leading platform to accelerate MedTech Regulatory Approvals. Start using Essenvia today to accelerate the approval of 510(k)/MDR applications.

[Essenvia @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?

[Essenvia @essenvia]

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!

[Essenvia @essenvia]

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 🚀

[Essenvia @essenvia]

Hey #regulatoryaffairs pros - are you ready for @US_FDA's eStar in October? Hit the EASY button with Essenvia & get 100% acceptance: https://t.co/PrlXZixB5e

[Essenvia @essenvia]

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

[BGV @BGVcapital]

Congratulations @essenvia on this milestone!

We are proud to lead this funding alongside @Wavemaker360.

#enterprise40 #crossborder #innovation

[Essenvia @essenvia]

We're thrilled to announce we just raised $4M in funding with @BGVcapital and @Wavemaker360 to help MedTech regulatory teams supercharge their regulatory submissions: https://t.co/PmgbVc4M8D

#MedicalDevices #regulatory #MEDTECH

[Essenvia @essenvia]

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!

[Essenvia @essenvia]

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: https://t.co/QIm3ZxUnqG

[Essenvia @essenvia]

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

[Essenvia @essenvia]

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.

https://t.co/HTNd28kc9M

#medicaldevices

[Essenvia @essenvia]

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

https://t.co/UfOo8gzqdC

[Essenvia @essenvia]

In Sept alone, the #FDA added 14 new #GuidanceDocuments: https://t.co/gVkEb7lXl2

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.

https://t.co/Ro1pUB1yYk

[Essenvia @essenvia]

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

[Essenvia @essenvia]

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!

https://t.co/oyBnl9jQIH

[Essenvia @essenvia]

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: https://t.co/0Qz8Xq6WK0

[Essenvia @essenvia]

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

[Essenvia @essenvia]

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

https://t.co/Jmsx8VU0B0

[Essenvia @essenvia]

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

https://t.co/bzwqoxzFnH

[Essenvia @essenvia]

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:  https://t.co/A72IyQl5Ks

#fdaclearance