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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

Medtech Regulatory, Medical Device, Medical Device Consultancy, Medtech Consulting, Medtech Consultant,

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

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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

MedTech Regulatory Insights January 2025

Uncategorized / February 3, 2025 / sanikakulkarni / Medical Device Regulatory Affairs, Medical Device Regulatory Affairs in India, Medical Device Regulatory Consultant, Medtech Consulting, Medtech Regulatory, Regulatory Affairs Agency

Medtech Regulatory, Medtech Consulting, Medical Device Regulatory Affairs, Regulatory Affairs Agency,

On 16 October 2024, the Medical Device Coordination Group (MDCG) published the revised guidance titled “Application of MDR Requirements to

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UncategorizedMedical Device Regulatory Affairs, Medical Device Regulatory Affairs in India, Medical Device Regulatory Consultant, Medtech Consulting, Medtech Regulatory, Regulatory Affairs Agency

STATISTICS 101: TYPES OF DATA

Uncategorized / December 17, 2024 / atonu dutta / Med Device Quality Consulting, Medical Device Consultant, Medical Device Regulatory Affairs Consultant near me, Medical Device Regulatory Consultants in India, Medtech Consulting, Statistics, Types of Data

Statistics, Types of Data, Medtech Consulting, Medical Device Consultant, Med Device Quality Consulting,

An understanding of statistics is useful whenever you are anaylsing any types of data and want to take actions based

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UncategorizedMed Device Quality Consulting, Medical Device Consultant, Medical Device Regulatory Affairs Consultant near me, Medical Device Regulatory Consultants in India, Medtech Consulting, Statistics, Types of Data

WHO Prequalification of In-Vitro diagnostics

Uncategorized / December 17, 2024 / atonu dutta / FDA guidelines for medical devices PDF, In Vitro diagnostics, Med Device Quality Consulting, Medtech Consulting, Pharma Regulatory Consulting Firms, Regulatory Consultant, who

In Vitro diagnostics, who, Med Device Quality Consulting, Regulatory Consultant,

WHO PQ: What, How, and WHY? The World Health Organisation Prequalification (WHO PQ) programme helps countries with low and medium-level

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UncategorizedFDA guidelines for medical devices PDF, In Vitro diagnostics, Med Device Quality Consulting, Medtech Consulting, Pharma Regulatory Consulting Firms, Regulatory Consultant, who

Uncovering the Impact of Endocrine Disrupting Substances in Biological Evaluation of Medical Devices

Uncategorized / December 17, 2024 / atonu dutta / Medical device, Medical Device Consultancy, Medical Device Consultant, Medical device consulting companies in India, Medical device consulting in India, Medical device consulting services, Medtech Consulting

Medical device, Medical Device Consultancy, Medtech Consulting, Medical Device Consultant,

In recent years, there has been growing concern about the presence of endocrine-disrupting substances (EDS) in various products, including medical

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

Blog on Biomaterials

Uncategorized / December 17, 2024 / atonu dutta / Biomaterials, Med Device Quality Consulting, Medical Device Consultancy, Medical Device Manufacturing Consultant, Medical Device Regulatory Consultant, Medtech Consulting

Biomaterials, Medical Device Manufacturing Consultant, Medtech Consulting, Medical Device Consultancy,

Thanks to their adaptability, resilience, and cost-effectiveness, biomaterials have long been a mainstay in medical device manufacturing. However, the environmental

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UncategorizedBiomaterials, Med Device Quality Consulting, Medical Device Consultancy, Medical Device Manufacturing Consultant, Medical Device Regulatory Consultant, Medtech Consulting

GOOD DOCUMENTATION PRACTICES

Uncategorized / December 16, 2024 / atonu dutta / Med Device Quality Consulting, Medtech Consulting, Quality Assurance Consultation, Quality Assurance Consulting, Quality Assurance Consulting for Medical Devices, Quality Management System

Quality Management System, Med Device Quality Consulting, Quality Assurance Consulting, Medtech Consulting,

Good Documentation Practices (GDP) serve as the foundational elements of a robust Quality Management System. Mandated by numerous regulatory bodies,

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UncategorizedMed Device Quality Consulting, Medtech Consulting, Quality Assurance Consultation, Quality Assurance Consulting, Quality Assurance Consulting for Medical Devices, Quality Management System

Advantages of an eQMS Software

Uncategorized / December 7, 2024 / sanikakulkarni / eQMS, Medical Device Regulatory Consultant, Medical Device Regulatory Consulting, Medtech Consulting, QMS, Quality Management System, Regulatory Affairs Consulting

eQMS, Medical Device Regulatory Consulting, Quality Management System, QMS, Medtech Consulting,

Are you finding it overwhelming to maintain and keep track of your Quality Management System (QMS), ensuring compliance with regulatory

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UncategorizedeQMS, Medical Device Regulatory Consultant, Medical Device Regulatory Consulting, Medtech Consulting, QMS, Quality Management System, Regulatory Affairs Consulting

Clinical evaluation of medical device

Uncategorized / November 30, 2024 / atonu dutta / CE for Medical Device, Clinical Evaluation, Medical device, Medical Device Consultancy, Medical Device Consultant, Medical device consulting companies in India, Medical device consulting in India, Medical Device Manufacturing Consultant, Medical Device Regulatory Consultant, Medtech Consulting

Medical Device, Clinical Evaluation, Medical device consulting in India, Medtech Consulting ,

Clinical Evaluation of Medical Devices Since the medical device regulation (EU) 2017/745 by the European Union started getting enforced, manufacturers

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UncategorizedCE for Medical Device, Clinical Evaluation, Medical device, Medical Device Consultancy, Medical Device Consultant, Medical device consulting companies in India, Medical device consulting in India, Medical Device Manufacturing Consultant, Medical Device Regulatory Consultant, Medtech Consulting