Expert Articles

Busting Naysayer Myths Around MedTech RIM Platforms

Essenvia Insights: Collisions Are Inevitable at the Crossroads of MedTech Regulation and Device Innovation. Exhibit A: EU’s MDR Fender Bender (Part 2 of 2)

Essenvia Insights: ‘Checkpoints’ or ‘Obstacles’? For Device Innovation, MedTech Regulation Can be Friend and Foe (Part 1 of 2)

Essenvia Insights: 8 Expert Tips for Cleaning Up SOPs Before FDA’s QMSR Reg Takes Effect (Part 2 of 2)

Essenvia Insights: 8 Expert Tips for Cleaning Up SOPs Before FDA’s QMSR Reg Takes Effect (Part 1 of 2)

5 Hot Regulatory Topics MedTech Experts Should Know to Prep for RAPS Convergence 2024

EU MDR: A MedTech RIM Platform Can Play a Vital Supporting Role as Companies Transition to New Reg

Achieving Regulatory Excellence Takes Commitment, Drive, Determination

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

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?

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

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

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