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March 2025

MedTech Regulatory Insights March 2025

Uncategorized / March 6, 2025 / sanikakulkarni / Medical device, Medical Device Consultancy, Medical device consulting in India, Medical Device Regulatory Consultant, Medtech Consulting, Medtech Regulatory

EMA INTRODUCES REGULAR SCIENTIFIC ADVICE PROCESS FOR HIGH-RISK MEDICAL DEVICES On January 17, 2025, the European Medicines Agency (EMA) published […]

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UncategorizedMedical device, Medical Device Consultancy, Medical device consulting in India, Medical Device Regulatory Consultant, Medtech Consulting, Medtech Regulatory

Post-Market Surveillance Requirements for Medical Devices in JAPAN

Uncategorized / March 3, 2025 / sanikakulkarni / Medical Device Consultancy, Medical Device Consultants in India, Medical device consulting services, Medical Device Regulatory Consultants in India, Medtech Consulting, Post-Market Surveillance

Post-Market Surveillance, Medical Device Consultancy, Medtech Consulting, Risk Management, PMDA,

The Pharmaceutical and Medical Device Act (PMD Act) governs medical devices in Japan, which sets the requirements for pre-market approval

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UncategorizedMedical Device Consultancy, Medical Device Consultants in India, Medical device consulting services, Medical Device Regulatory Consultants in India, Medtech Consulting, Post-Market Surveillance

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Mastering the Clinical Evaluation Report (CER) May 28, 2025
Understanding CMR and Endocrine-Disrupting Substances in Medical Devices May 13, 2025
Root Cause Analysis: The 5-Why Technique May 8, 2025
MedTech Regulatory Insights May 2025 May 6, 2025
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