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ISO 14155:2026: What Medical Device Teams Need to Know

In March 2026, ISO published the fourth edition of ISO 14155, replacing the third edition

AI-Accelerated Development, FDA-Ready Evidence

An established global medical device manufacturer sought AlvaMed’s support in assessing a new web-based medical

Supporting Software Due Diligence for a High-Risk Medical Device Acquisition

Background A global medical device company was evaluating the acquisition of an international manufacturer developing

Building a Global Quality Management System for a Clinical-Stage Combination Product Company

A clinical-stage company developing a gene therapy combination product for hearing restoration was preparing for

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

Defining the Regulatory Pathway for a Novel 3D Imaging Technology

Guiding a Pioneering Technology Through FDA Strategy and Clinical Alignment A medical device innovator developing

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

Strengthening FDA Inspection Readiness Through Targeted QMSR & ISO 13485 Training

Overview A mid-sized medical device organization engaged AlvaMed to deliver a targeted, full-day training program

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

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A monthly analysis of the medical device industry, quality and regulatory developments, and other useful information for industry professionals. (Contact details are never shared outside our organization.)