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ALCEON CONSULTING
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MedTech Regulatory
Regulatory Radar Australia Enforces UDI Regulations – New Era for Device Traceability Begins Australia’s Unique Device Identification (UDI) regulations are now in effect, marking a...

ENTERING CHINA’S BOOMING HEALTHCARE MARKET: REGULATORY ROADMAP AND THE CHALLENGES.
Entering China’s Booming Healthcare Market: Regulatory Roadmap and the Challenges. Why CHINA? China’s $170 billion Medical Device market (projected by 2025) offers strong growth potential due to:...

Water in Medical Device Manufacturing: TYPES, USES & STANDARDS
Water in Medical Device Manufacturing: Types, Uses & Standards Water is more than just H₂O in the medical device world. It’s a critical raw material...

REGISTRATION OF MEDICAL DEVICES IN BRAZIL
ANVISA, which stands for Agência Nacional de Vigilância Sanitária, is Brazil’s National Health Surveillance Role and Responsibilities: ANVISA’s primary mission is to protect public health...