Healthline

The FDA Development and Approval Process for Medications and Medical Devices

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...
Digital Journal

Streamlining regulatory compliance and quality assurance with a data-driven approach to medical device development

The advent of artificial intelligence (AI) and data-driven methodologies has triggered a wave of transformation in regulatory compliance and quality assurance for the development of medical devices.
MD&M East

FDA Staff Cuts & Global Tariffs Pose Challenges for Medical Device Development, Experts Warn

During an April 7 session of the Biopharma Congress, Janet Woodcock, MD, former acting FDA Commissioner and former principal deputy commissioner of food and drugs, called the recent FDA staff cuts a ...
MobiHealthNews

Q&A: A doctor's opinion on the FDA AI certification process

According to the Food and Drug Administration (FDA), the traditional paradigm of medical device regulation was not designed for adaptive artificial intelligence and machine learning technologies. As a ...

Contract Manufacturing of Medical Devices Global Markets Report 2025-2030: Growth Driven by Aging Populations, Rising Chronic Disease Burden, and OEM Shift Toward ISO- and FDA ...

The global market for contract manufacturing of medical devices is estimated to grow from $96.4 billion in 2025 to reach $155.2 billion by 2030, at a compound annual growth rate (CAGR) of 10% from ...