AlvaMed Strengthens AI Expertise with MIT Sloan Executive Education Certification
We’re pleased to share that AlvaMed President & Founder Mark Cox has successfully completed MIT Sloan Executive Education’s AI Adoption: Driving Business Value and Impact program and earned a professional certificate. While this achievement further strengthens our expertise, AlvaMed has been actively preparing for the growing role of artificial intelligence in MedTech for some time. As AI-enabled […]
AlvaMed Welcomes Alexia Haralambous as Vice President of Regulatory Affairs
AlvaMed is pleased to announce that Alexia Haralambous, MS, RAC has joined the firm as Vice President of Regulatory Affairs, where she will lead and continue to expand the company’s regulatory consulting practice. Alexia brings over a decade of experience across the FDA, MedTech industry, and consulting, including serving as a former FDA reviewer. She […]
From Startup to Acquisition: Scaling a MedTech Innovator from Concept to Exit
Supporting a Three-Person Startup from Foundation to Acquisition When a three-person wound care startup company approached AlvaMed, they had a promising concept and an early-stage design they believed would meet market needs. What they did not yet have was the regulatory and quality infrastructure, a quality system, or a strategic roadmap necessary to bring a […]
FDA AI Review Tools: What the Elsa Transition Means for Regulatory Strategy
The FDA is migrating its internal AI tool Elsa from Claude to Gemini. Learn how this shift may affect regulatory reviews, submission strategy, and FDA timelines. For companies preparing medical device or pharmaceutical regulatory submissions to the FDA, these developments reinforce the importance of clear documentation and proactive regulatory planning. What Is Elsa? The FDA’s […]
Your Practical Roadmap to FDA QMSR Compliance
QMSR Transition Guide The FDA’s Quality Management System Regulation (QMSR) replaces 21 CFR 820 and aligns U.S. requirements with ISO 13485:2016 — with important FDA-specific additions. Transitioning requires more than terminology updates. It demands structured planning, risk integration, updated documentation, and inspection readiness. AlvaMed’s QMSR Transition Guide provides a clear, step-by-step framework to help your […]
Navigate the Shifting MedTech Regulatory Landscape with Confidence
Navigate the Shifting MedTech Regulatory Landscape with Confidence Your 2026 Strategy Guide for MedTech Leaders In today’s fluid regulatory environment, success is no longer just about compliance—it’s about setting the right expectations and building resilience into your development timeline. With regulatory timelines more variable than they have been in years, staffing shifts and global divergence […]
Computer Software Assurance for Production and Quality System Software
FDA recently issued a guidance document on “Computer Software Assurance for Production and Quality System Software”. This guidance offers clear, practical recommendations for validating software used in medical device production and quality systems. Designed to support compliance with 21 CFR Part 820, this guidance builds on the foundational “General Principles of Software Validation”. It emphasizes […]
To eQMS or Not: The Enduring Value of a Traditional QMS in a Digital Age
In today’s fast-paced, digital-first world, the allure of electronic Quality Management Systems (eQMS) is undeniable. Streamlined workflows, instant data access, and automated reporting – it all sounds incredibly efficient. But amidst the digital buzz, there’s still a place for the stalwart, traditional paper-based QMS. While often perceived as outdated, a paper system can offer unique […]
Impact of Medical Device Supply Chain Vulnerabilities on Public Health
The U.S. Food and Drug Administration (FDA) is focused on preventing and mitigating medical device shortages, which pose significant risks to patient care, particularly for vulnerable populations like neonatal and pediatric patients. From premature infants in neonatal intensive care units to children with chronic illnesses requiring long-term medical interventions, the need for appropriately sized, high-quality […]
Rethinking eQMS: When a Traditional QMS Might be Right
An eQMS system, or electronic Quality Management System, is a software solution designed to automate and streamline quality management processes within an organization. It replaces traditional paper-based systems with a digital centralized platform for managing documents, workflows, and quality-related activities. While eQMS systems offer automation and streamlined workflows, they aren’t always the best fit for […]
