Naveen Agarwal on Muck Rack

Naveen Agarwal

Verified
Florida
As seen in: Let's Talk Risk!, The Times of India, MDPI, International Journal of Electronic Business, Springer Professional, Med Device Online, The Journal of Musculoskeletal Surgery and Research (JMSR)
Let’s Talk Risk! is all about connecting, sharing and learning together. Because there is more than one way to manage risk and no one has all the answers.
Is this you? As a journalist, you can create a free Muck Rack account to customize your profile, list your contact preferences, and upload a portfolio of your best work. Claim your profile

Get in touch with Naveen

Contact Naveen, search articles and posts on X, monitor coverage, and track replies from one place.

Learn more about Muck Rack

Actions

Share this page

Is this you?

As a journalist, you can create a free Muck Rack account to customize your profile, list your contact preferences, and upload a portfolio of your best work.
Claim your profile

Articles

TAI #30: Is Your PMS Managing Risk or Just Documenting Complaints?

|
By Naveen Agarwal Verified
| Let's Talk Risk!
Dear colleagues: In MedTech, many organizations believe they have an active Post-Market Surveillance (PMS) process. But in practice, what they mostly have is vigilance. They gather complaints, review events, and decide whether something must be reported for regulatory purposes. That work is necessary. But it is not the same as active surveillance. That distinction matters because vigilance is mostly reactive.
Open in Who Shared Issue with article?

Case Study: FDA’s New Expectation for Use-Related Risk in Medical Device Submissions

|
By Naveen Agarwal Verified
| Let's Talk Risk!
You cannot reverse engineer your human factors regulatory strategy at the 11th hour. FDA’s new human factors guidance is not just about what goes into a marketing submission. It changes the way teams need to think about use-related risk, critical tasks, labeling, training, post-market evidence, and design change control across the product lifecycle.
Open in Who Shared Issue with article?

QMSR QuickTake #29: The Shift to Top Management Under QMSR

|
By Naveen Agarwal Verified
| Let's Talk Risk!
In responding to Comment #27 in the preamble of the QMSR1, FDA appears to address a terminology change. But the agency's response points to a broader shift in how leadership accountability is viewed within the quality management system. Several commenters asked FDA to retain the former QS Regulation term "management with executive responsibility." FDA disagreed and instead adopted the ISO 9000 concept of top management. At first glance, this may appear to be a minor change in wording.
Open in Who Shared Issue with article?
See all 253 licensed articles (254 Total)
 •  Privacy  •  Terms  •  Security and Legal  •   •   •   • 

© 2026 Muck Rack

SOC 2® Certified