Skip To Main Content
Apekshit Mhatre on Muck Rack

Apekshit Mhatre

As seen in: Med Device Online
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
Back to Apekshit Mhatre’s profile

Articles by Apekshit Mhatre

03.07.26 -- February's Most Popular Articles & Solutions

|
By Srividya Narayanan, Asahi Intecc, Apekshit Mhatre
| Med Device Online
Let's take a closer look at how AI-enabled medical devices and their QMS should be compliant with the EU MDR and the EU AI Act while also adhering to applicable ISO standards. The FDA’s implementation of AI tools marks the next step in the agency’s digital transformation efforts. Let's take a closer look at how this impacts 510(k) submissions and tips for preparing your submissions.
Open in Who Shared Issue with article?

02.22.26 -- Building The AI-Enabled Medical Device QMS For European Compliance

|
By Srividya Narayanan, Asahi Intecc, Apekshit Mhatre
| Med Device Online
Get the latest industry news and expert insights delivered straight to your inbox! Newsletter | February 22, 2026
Open in Who Shared Issue with article?

Building The AI-Enabled Medical Device QMS For European Compliance

|
By Srividya Narayanan, Asahi Intecc, Apekshit Mhatre
| Med Device Online
By Srividya Narayanan, MSc, CQSP, Asahi Intecc; and Apekshit Mhatre, Northeastern University With the increasing use of AI in medical devices, there are complex requirements, as ISO 13485:2016 serves as the foundation for quality assurance in medical devices.1 We now have a quality regulation in place, as outlined in the EU AI Act, with Article 17 providing specific requirements for AI.2 Internationally, we had a gap filled with ISO/IEC 42001:2023, which provides the first standard for AI...
Open in Who Shared Issue with article?
Show More