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Articles by Srividya Narayanan
AI Transparency Gap in SaMD Regulation
Artificial intelligence is no longer on the horizon of medical device regulation — it’s already on regulators’ desks. The FDA’s iterative guidance on AI/ML-based Software as a Medical Device (SaMD), the EU AI Act’s risk classification scheme, and Health Canada’s adoption of International Medical Device Regulators Forum (IMDRF) principles all send the same message: algorithmic transparency is becoming a compliance expectation, not just a design aspiration. But a major gap remains.
If Your AI Can't Explain Itself, Can FDA Authorize It?
Consider a hypothetical scenario that reflects a pattern increasingly reported by manufacturers: a 510(k) submission for an AI-powered diagnostic tool with 99% sensitivity. Strong numbers. Solid validation. And yet — a deficiency letter comes back from FDA. Not because the model underperforms. Because reviewers cannot determine what it is actually doing or why. This is the reality manufacturers are running into as AI/ML-based Software as a Medical Device (SaMD) enters the 510(k) and De Novo pathways.
From Toddlers to Teens: The Hidden Complexities of Bringing Pediatric Wearables to Market
Pediatric wearables are often treated as a niche extension of adult digital health, but that framing misses the real challenge. The hardest part is not miniaturizing the technology for smaller bodies. It is designing for a patient population that is constantly changing (physically, cognitively, behaviorally, and clinically) from infancy through adolescence.
03.07.26 -- February's Most Popular Articles & Solutions
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.
02.22.26 -- Building The AI-Enabled Medical Device QMS For European Compliance
Get the latest industry news and expert insights delivered straight to your inbox! Newsletter | February 22, 2026
Building The AI-Enabled Medical Device QMS For European Compliance
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...
Op-ed: It is time for Northeastern to back its emerging leaders on the global stage
When I enrolled in Northeastern’s College of Professional Studies, or CPS, as a master’s regulatory affairs student, I never imagined that within a short time span, I would be speaking at international conferences in the U.S., Spain and Germany, winning global competitions and representing the university on stages as a keynote and oral speaker across the world. What I also did not expect was how often I would be doing that on my own.
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