Stay up-to-date with the latest news and articles written by our team of experts to assist medical device companies in navigating trends and challenges in regulatory affairs, quality management systems and clinical affairs.
AlvaMed is pleased to announce that Alexia Haralambous, MS, RAC has joined the firm as
Supporting a Three-Person Startup from Foundation to Acquisition When a three-person wound care startup company
The FDA is migrating its internal AI tool Elsa from Claude to Gemini. Learn how
QMSR Transition Guide The FDA’s Quality Management System Regulation (QMSR) replaces 21 CFR 820 and
Navigate the Shifting MedTech Regulatory Landscape with Confidence Your 2026 Strategy Guide for MedTech Leaders
FDA recently issued a guidance document on “Computer Software Assurance for Production and Quality System
In today’s fast-paced, digital-first world, the allure of electronic Quality Management Systems (eQMS) is undeniable.
The U.S. Food and Drug Administration (FDA) is focused on preventing and mitigating medical device
An eQMS system, or electronic Quality Management System, is a software solution designed to automate
