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FDA

Regulatory Operations

510(k)

Product Updates

Company News

Dhriti Roy

Mar 22, 2024

The Pathway to Regulatory Excellence for MedTech Manufacturers: 20 Key Best Practices

FDA

Soumya Mahapatra

Jan 25, 2024

What is Regulatory Excellence? And Why it is Critical for MedTech Companies.

FDA

Soumya Mahapatra

Jan 25, 2024

The impact of modern Regulatory (RIM) technology on time to market

FDA

Soumya Mahapatra

Jan 25, 2024

Why use a Regulatory (RIM) Platform to manage Product Registrations?

FDA

Soumya Mahapatra

Jan 25, 2024

Change Assessement in Medical Devices: Understanding Regulatory Implications

FDA

Soumya Mahapatra

Jan 25, 2024

How can RA teams take advantage of Regulatory Intelligence?

FDA

Soumya Mahapatra

Nov 3, 2023

Modern Regulatory (RIM) Platforms and Class III PMA

FDA

Soumya Mahapatra

Nov 3, 2023

10 key steps to navigate the new eSTAR Submission Process

FDA

Dhriti Roy

Nov 3, 2023

How to Handle Pre-Sub and Q-Sub Strategy for FDA Submissions

FDA

Soumya Mahapatra

Oct 19, 2023

Highlights of RAPS Convergence 2023: eSTAR takes center stage

FDA

510(k)

Soumya Mahapatra

Oct 21, 2021

What does FDA Cleared vs. FDA Approved mean for Medical Devices?

FDA

Soumya Mahapatra

Aug 2, 2023

What is Section 513(g) and How Does it Work

FDA

Soumya Mahapatra

Jul 28, 2023

Your Guide to the FDA eSTAR program

FDA

Regulatory Operations

Dhriti Roy

Jul 14, 2023

MDCG guidelines on the Periodic Safety Update Report (PSUR) - How can IVD Manufacturers Benefit

Regulatory Operations

Soumya Mahapatra

May 2, 2023

Why We Raised $4M to Supercharge MedTech Regulatory Submissions

Company News

Soumya Mahapatra

Mar 18, 2022

How to Document Risk in your 510(k)

510(k)

Soumya Mahapatra

Feb 9, 2022

The Ultimate Guide to Medical Device Classification for US FDA and European Union’s Medical Device Regulation (MDR)

FDA

Soumya Mahapatra

Feb 8, 2022

Your Guide to European CE Mark for Medical Devices

Regulatory Operations

Soumya Mahapatra

Dec 30, 2021

510k vs PMA Submissions for Medical Devices in the United States

510(k)

Regulatory Operations

Soumya Mahapatra

Dec 16, 2021

What is GSPR (General Safety And Performance Requirements) for EU MDR and EU IVDR?

FDA

Soumya Mahapatra

Sep 23, 2021

How Essenvia’s Latest Updates Help Create An Accurate Regulatory Submission

Product Updates

Regulatory Operations

Soumya Mahapatra

Sep 20, 2021

What do Regulatory Specialists need to know about searching the FDA 510(k) Database for Regulatory Strategy

Product Updates

Regulatory Operations

Soumya Mahapatra

Sep 9, 2021

How Medical Device Companies Can Gain A Competitive Advantage By Transforming Their Regulatory Affairs Operations

Product Updates

Company News

Soumya Mahapatra

Sep 8, 2021

Essenvia Product Workspace: All Your Medical Device Data In One Place

Company News

Product Updates

Soumya Mahapatra

Sep 8, 2021

5 Reasons You Shouldn’t Work on Your 510(k) Submission Alone

510(k)

Soumya Mahapatra

Sep 8, 2021

The Top 5 Reasons The FDA Rejects A 510(k) Submission

FDA

510(k)

All Articles

FDA

Regulatory Operations

510(k)

Product Updates

Company News

Dhriti Roy

Mar 22, 2024

The Pathway to Regulatory Excellence for MedTech Manufacturers: 20 Key Best Practices

FDA

Soumya Mahapatra

Jan 25, 2024

What is Regulatory Excellence? And Why it is Critical for MedTech Companies.

FDA

Soumya Mahapatra

Jan 25, 2024

The impact of modern Regulatory (RIM) technology on time to market

FDA

Soumya Mahapatra

Jan 25, 2024

Why use a Regulatory (RIM) Platform to manage Product Registrations?

FDA

Soumya Mahapatra

Jan 25, 2024

Change Assessement in Medical Devices: Understanding Regulatory Implications

FDA

Soumya Mahapatra

Jan 25, 2024

How can RA teams take advantage of Regulatory Intelligence?

FDA

Soumya Mahapatra

Nov 3, 2023

Modern Regulatory (RIM) Platforms and Class III PMA

FDA

Soumya Mahapatra

Nov 3, 2023

10 key steps to navigate the new eSTAR Submission Process

FDA

Dhriti Roy

Nov 3, 2023

How to Handle Pre-Sub and Q-Sub Strategy for FDA Submissions

FDA

Soumya Mahapatra

Oct 19, 2023

Highlights of RAPS Convergence 2023: eSTAR takes center stage

FDA

510(k)

Soumya Mahapatra

Oct 21, 2021

What does FDA Cleared vs. FDA Approved mean for Medical Devices?

FDA

Soumya Mahapatra

Aug 2, 2023

What is Section 513(g) and How Does it Work

FDA

Soumya Mahapatra

Jul 28, 2023

Your Guide to the FDA eSTAR program

FDA

Regulatory Operations

Dhriti Roy

Jul 14, 2023

MDCG guidelines on the Periodic Safety Update Report (PSUR) - How can IVD Manufacturers Benefit

Regulatory Operations

Soumya Mahapatra

May 2, 2023

Why We Raised $4M to Supercharge MedTech Regulatory Submissions

Company News

Soumya Mahapatra

Mar 18, 2022

How to Document Risk in your 510(k)

510(k)

Soumya Mahapatra

Feb 9, 2022

The Ultimate Guide to Medical Device Classification for US FDA and European Union’s Medical Device Regulation (MDR)

FDA

Soumya Mahapatra

Feb 8, 2022

Your Guide to European CE Mark for Medical Devices

Regulatory Operations

Soumya Mahapatra

Dec 30, 2021

510k vs PMA Submissions for Medical Devices in the United States

510(k)

Regulatory Operations

Soumya Mahapatra

Dec 16, 2021

What is GSPR (General Safety And Performance Requirements) for EU MDR and EU IVDR?

FDA

Soumya Mahapatra

Sep 23, 2021

How Essenvia’s Latest Updates Help Create An Accurate Regulatory Submission

Product Updates

Regulatory Operations

Soumya Mahapatra

Sep 20, 2021

What do Regulatory Specialists need to know about searching the FDA 510(k) Database for Regulatory Strategy

Product Updates

Regulatory Operations

Soumya Mahapatra

Sep 9, 2021

How Medical Device Companies Can Gain A Competitive Advantage By Transforming Their Regulatory Affairs Operations

Product Updates

Company News

Soumya Mahapatra

Sep 8, 2021

Essenvia Product Workspace: All Your Medical Device Data In One Place

Company News

Product Updates

Soumya Mahapatra

Sep 8, 2021

5 Reasons You Shouldn’t Work on Your 510(k) Submission Alone

510(k)

Soumya Mahapatra

Sep 8, 2021

The Top 5 Reasons The FDA Rejects A 510(k) Submission

FDA

510(k)

All Articles

FDA

Regulatory Operations

510(k)

Product Updates

Company News

Dhriti Roy

Mar 22, 2024

The Pathway to Regulatory Excellence for MedTech Manufacturers: 20 Key Best Practices

FDA

Soumya Mahapatra

Jan 25, 2024

What is Regulatory Excellence? And Why it is Critical for MedTech Companies.

FDA

Soumya Mahapatra

Jan 25, 2024

The impact of modern Regulatory (RIM) technology on time to market

FDA

Soumya Mahapatra

Jan 25, 2024

Why use a Regulatory (RIM) Platform to manage Product Registrations?

FDA

Soumya Mahapatra

Jan 25, 2024

Change Assessement in Medical Devices: Understanding Regulatory Implications

FDA

Soumya Mahapatra

Jan 25, 2024

How can RA teams take advantage of Regulatory Intelligence?

FDA

Soumya Mahapatra

Nov 3, 2023

Modern Regulatory (RIM) Platforms and Class III PMA

FDA

Soumya Mahapatra

Nov 3, 2023

10 key steps to navigate the new eSTAR Submission Process

FDA

Dhriti Roy

Nov 3, 2023

How to Handle Pre-Sub and Q-Sub Strategy for FDA Submissions

FDA

Soumya Mahapatra

Oct 19, 2023

Highlights of RAPS Convergence 2023: eSTAR takes center stage

FDA

510(k)

Soumya Mahapatra

Oct 21, 2021

What does FDA Cleared vs. FDA Approved mean for Medical Devices?

FDA

Soumya Mahapatra

Aug 2, 2023

What is Section 513(g) and How Does it Work

FDA

Soumya Mahapatra

Jul 28, 2023

Your Guide to the FDA eSTAR program

FDA

Regulatory Operations

Dhriti Roy

Jul 14, 2023

MDCG guidelines on the Periodic Safety Update Report (PSUR) - How can IVD Manufacturers Benefit

Regulatory Operations

Soumya Mahapatra

May 2, 2023

Why We Raised $4M to Supercharge MedTech Regulatory Submissions

Company News

Soumya Mahapatra

Mar 18, 2022

How to Document Risk in your 510(k)

510(k)

Soumya Mahapatra

Feb 9, 2022

The Ultimate Guide to Medical Device Classification for US FDA and European Union’s Medical Device Regulation (MDR)

FDA

Soumya Mahapatra

Feb 8, 2022

Your Guide to European CE Mark for Medical Devices

Regulatory Operations

Soumya Mahapatra

Dec 30, 2021

510k vs PMA Submissions for Medical Devices in the United States

510(k)

Regulatory Operations

Soumya Mahapatra

Dec 16, 2021

What is GSPR (General Safety And Performance Requirements) for EU MDR and EU IVDR?

FDA

Soumya Mahapatra

Sep 23, 2021

How Essenvia’s Latest Updates Help Create An Accurate Regulatory Submission

Product Updates

Regulatory Operations

Soumya Mahapatra

Sep 20, 2021

What do Regulatory Specialists need to know about searching the FDA 510(k) Database for Regulatory Strategy

Product Updates

Regulatory Operations

Soumya Mahapatra

Sep 9, 2021

How Medical Device Companies Can Gain A Competitive Advantage By Transforming Their Regulatory Affairs Operations

Product Updates

Company News

Soumya Mahapatra

Sep 8, 2021

Essenvia Product Workspace: All Your Medical Device Data In One Place

Company News

Product Updates

Soumya Mahapatra

Sep 8, 2021

5 Reasons You Shouldn’t Work on Your 510(k) Submission Alone

510(k)

Soumya Mahapatra

Sep 8, 2021

The Top 5 Reasons The FDA Rejects A 510(k) Submission

FDA

510(k)

All Articles

FDA

Regulatory Operations

510(k)

Product Updates

Company News

Dhriti Roy

Mar 22, 2024

The Pathway to Regulatory Excellence for MedTech Manufacturers: 20 Key Best Practices

FDA

Soumya Mahapatra

Jan 25, 2024

What is Regulatory Excellence? And Why it is Critical for MedTech Companies.

FDA

Soumya Mahapatra

Jan 25, 2024

The impact of modern Regulatory (RIM) technology on time to market

FDA

Soumya Mahapatra

Jan 25, 2024

Why use a Regulatory (RIM) Platform to manage Product Registrations?

FDA

Soumya Mahapatra

Jan 25, 2024

Change Assessement in Medical Devices: Understanding Regulatory Implications

FDA

Soumya Mahapatra

Jan 25, 2024

How can RA teams take advantage of Regulatory Intelligence?

FDA

Soumya Mahapatra

Nov 3, 2023

Modern Regulatory (RIM) Platforms and Class III PMA

FDA

Soumya Mahapatra

Nov 3, 2023

10 key steps to navigate the new eSTAR Submission Process

FDA

Dhriti Roy

Nov 3, 2023

How to Handle Pre-Sub and Q-Sub Strategy for FDA Submissions

FDA

Soumya Mahapatra

Oct 19, 2023

Highlights of RAPS Convergence 2023: eSTAR takes center stage

FDA

510(k)

Soumya Mahapatra

Oct 21, 2021

What does FDA Cleared vs. FDA Approved mean for Medical Devices?

FDA

Soumya Mahapatra

Aug 2, 2023

What is Section 513(g) and How Does it Work

FDA

Soumya Mahapatra

Jul 28, 2023

Your Guide to the FDA eSTAR program

FDA

Regulatory Operations

Dhriti Roy

Jul 14, 2023

MDCG guidelines on the Periodic Safety Update Report (PSUR) - How can IVD Manufacturers Benefit

Regulatory Operations

Soumya Mahapatra

May 2, 2023

Why We Raised $4M to Supercharge MedTech Regulatory Submissions

Company News

Soumya Mahapatra

Mar 18, 2022

How to Document Risk in your 510(k)

510(k)

Soumya Mahapatra

Feb 9, 2022

The Ultimate Guide to Medical Device Classification for US FDA and European Union’s Medical Device Regulation (MDR)

FDA

Soumya Mahapatra

Feb 8, 2022

Your Guide to European CE Mark for Medical Devices

Regulatory Operations

Soumya Mahapatra

Dec 30, 2021

510k vs PMA Submissions for Medical Devices in the United States

510(k)

Regulatory Operations

Soumya Mahapatra

Dec 16, 2021

What is GSPR (General Safety And Performance Requirements) for EU MDR and EU IVDR?

FDA

Soumya Mahapatra

Sep 23, 2021

How Essenvia’s Latest Updates Help Create An Accurate Regulatory Submission

Product Updates

Regulatory Operations

Soumya Mahapatra

Sep 20, 2021

What do Regulatory Specialists need to know about searching the FDA 510(k) Database for Regulatory Strategy

Product Updates

Regulatory Operations

Soumya Mahapatra

Sep 9, 2021

How Medical Device Companies Can Gain A Competitive Advantage By Transforming Their Regulatory Affairs Operations

Product Updates

Company News

Soumya Mahapatra

Sep 8, 2021

Essenvia Product Workspace: All Your Medical Device Data In One Place

Company News

Product Updates

Soumya Mahapatra

Sep 8, 2021

5 Reasons You Shouldn’t Work on Your 510(k) Submission Alone

510(k)

Soumya Mahapatra

Sep 8, 2021

The Top 5 Reasons The FDA Rejects A 510(k) Submission

FDA

510(k)

Relevant Content forMedTech Regulatory Professionals

Relevant Content forMedTech Regulatory Professionals

Relevant Content forMedTech Regulatory Professionals

Relevant Content forMedTech Regulatory Professionals

The Pathway to Regulatory Excellence for MedTech Manufacturers: 20 Key Best Practices

What is Regulatory Excellence? And Why it is Critical for MedTech Companies.

The impact of modern Regulatory (RIM) technology on time to market

Why use a Regulatory (RIM) Platform to manage Product Registrations?

Change Assessement in Medical Devices: Understanding Regulatory Implications

How can RA teams take advantage of Regulatory Intelligence?

Modern Regulatory (RIM) Platforms and Class III PMA

10 key steps to navigate the new eSTAR Submission Process

How to Handle Pre-Sub and Q-Sub Strategy for FDA Submissions

Highlights of RAPS Convergence 2023: eSTAR takes center stage

What does FDA Cleared vs. FDA Approved mean for Medical Devices?

What is Section 513(g) and How Does it Work

Your Guide to the FDA eSTAR program

MDCG guidelines on the Periodic Safety Update Report (PSUR) - How can IVD Manufacturers Benefit

Why We Raised $4M to Supercharge MedTech Regulatory Submissions

How to Document Risk in your 510(k)

The Ultimate Guide to Medical Device Classification for US FDA and European Union’s Medical Device Regulation (MDR)

Your Guide to European CE Mark for Medical Devices

510k vs PMA Submissions for Medical Devices in the United States

What is GSPR (General Safety And Performance Requirements) for EU MDR and EU IVDR?

How Essenvia’s Latest Updates Help Create An Accurate Regulatory Submission

What do Regulatory Specialists need to know about searching the FDA 510(k) Database for Regulatory Strategy

How Medical Device Companies Can Gain A Competitive Advantage By Transforming Their Regulatory Affairs Operations

Essenvia Product Workspace: All Your Medical Device Data In One Place

5 Reasons You Shouldn’t Work on Your 510(k) Submission Alone

The Top 5 Reasons The FDA Rejects A 510(k) Submission

The Pathway to Regulatory Excellence for MedTech Manufacturers: 20 Key Best Practices

What is Regulatory Excellence? And Why it is Critical for MedTech Companies.

The impact of modern Regulatory (RIM) technology on time to market

Why use a Regulatory (RIM) Platform to manage Product Registrations?

Change Assessement in Medical Devices: Understanding Regulatory Implications

How can RA teams take advantage of Regulatory Intelligence?

Modern Regulatory (RIM) Platforms and Class III PMA

10 key steps to navigate the new eSTAR Submission Process

How to Handle Pre-Sub and Q-Sub Strategy for FDA Submissions

Highlights of RAPS Convergence 2023: eSTAR takes center stage

What does FDA Cleared vs. FDA Approved mean for Medical Devices?

What is Section 513(g) and How Does it Work

Your Guide to the FDA eSTAR program

MDCG guidelines on the Periodic Safety Update Report (PSUR) - How can IVD Manufacturers Benefit

Why We Raised $4M to Supercharge MedTech Regulatory Submissions

How to Document Risk in your 510(k)

The Ultimate Guide to Medical Device Classification for US FDA and European Union’s Medical Device Regulation (MDR)

Your Guide to European CE Mark for Medical Devices

510k vs PMA Submissions for Medical Devices in the United States

What is GSPR (General Safety And Performance Requirements) for EU MDR and EU IVDR?

How Essenvia’s Latest Updates Help Create An Accurate Regulatory Submission

What do Regulatory Specialists need to know about searching the FDA 510(k) Database for Regulatory Strategy

How Medical Device Companies Can Gain A Competitive Advantage By Transforming Their Regulatory Affairs Operations

Essenvia Product Workspace: All Your Medical Device Data In One Place

5 Reasons You Shouldn’t Work on Your 510(k) Submission Alone

The Top 5 Reasons The FDA Rejects A 510(k) Submission

The Pathway to Regulatory Excellence for MedTech Manufacturers: 20 Key Best Practices

What is Regulatory Excellence? And Why it is Critical for MedTech Companies.

The impact of modern Regulatory (RIM) technology on time to market

Why use a Regulatory (RIM) Platform to manage Product Registrations?

Change Assessement in Medical Devices: Understanding Regulatory Implications

How can RA teams take advantage of Regulatory Intelligence?

Modern Regulatory (RIM) Platforms and Class III PMA

10 key steps to navigate the new eSTAR Submission Process

How to Handle Pre-Sub and Q-Sub Strategy for FDA Submissions

Highlights of RAPS Convergence 2023: eSTAR takes center stage

What does FDA Cleared vs. FDA Approved mean for Medical Devices?

What is Section 513(g) and How Does it Work

Your Guide to the FDA eSTAR program

MDCG guidelines on the Periodic Safety Update Report (PSUR) - How can IVD Manufacturers Benefit

Why We Raised $4M to Supercharge MedTech Regulatory Submissions

How to Document Risk in your 510(k)

The Ultimate Guide to Medical Device Classification for US FDA and European Union’s Medical Device Regulation (MDR)

Your Guide to European CE Mark for Medical Devices

510k vs PMA Submissions for Medical Devices in the United States

What is GSPR (General Safety And Performance Requirements) for EU MDR and EU IVDR?

How Essenvia’s Latest Updates Help Create An Accurate Regulatory Submission

What do Regulatory Specialists need to know about searching the FDA 510(k) Database for Regulatory Strategy

How Medical Device Companies Can Gain A Competitive Advantage By Transforming Their Regulatory Affairs Operations

Essenvia Product Workspace: All Your Medical Device Data In One Place

Relevant Content for
MedTech Regulatory Professionals

Relevant Content for
MedTech Regulatory Professionals

Relevant Content for
MedTech Regulatory Professionals

Relevant Content for
MedTech Regulatory Professionals