Tag: Healthcare Innovation

Medical Devices – USA, Europe, Asia and ROW Regulatory News – May 2025

June 4, 2025
Medical Device

USA Guidance Document: Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program The aim of this guidance document is to outline the various mechanisms available...

Compliance, Digital Health, EU Regulations, FDA, Global Health, Healthcare Innovation, Med Tech, Medical Devices, Regulatory Affairs, UDI

Expanded OTC Approvals and Market Projections (2000-2040)

February 12, 2025
OTC

The Over-the-Counter (OTC) drug market has undergone significant evolution since the early 2000s. With increasing demand for self-medication, advancements in healthcare technology, and greater consumer...

Future of Pharma, Global Pharma Market, Healthcare Innovation, Healthcare Trends, OTC Drug Trends, OTC Drugs, OTC Market Growth, OTC Trends, Pharma Forecast, Pharma Growth 2040, Pharma Market

Streamlining Global Market Access with Medical Device Registration

November 19, 2024
Medical Device

Expanding into international markets is a significant milestone for medical device manufacturers. However, achieving global market access comes with its share of challenges—particularly meeting medical...

Compliance Management, Compliance Solutions, Global Market Access, Healthcare Innovation, Medical Device Compliance, Medical Device Registration, MedTech Solutions, Regulatory Intelligence, Regulatory Requirements

The Impact of AI on Medical Device Technology and Certification

October 16, 2024
Medical Device

Currently, AI refers to the ability of machines to perform cognitive tasks commonly associated with human intelligence including perception, learning, reasoning, planning, speech and language, and...

AI Algorithms, AI and Data, AI Impact, AI Med Tech, Data Science, Healthcare AI, Healthcare Innovation, Machine Learning, Medical Device Certification, Medical Devices