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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

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

MedTech Regulatory Insights Feb 2025

Uncategorized / February 3, 2025 / atonu dutta / Medical Device Regulatory Affairs, Medical Device Regulatory Affairs Consultant, Medical Device Regulatory Consultant, Medical Device Regulatory Consulting, Medtech Regulatory, Medtech Regulatory Insights

The FDA has released a draft of new recommendations aimed at improving the performance accuracy of pulse oximeters, particularly across

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UncategorizedMedical Device Regulatory Affairs, Medical Device Regulatory Affairs Consultant, Medical Device Regulatory Consultant, Medical Device Regulatory Consulting, Medtech Regulatory, Medtech Regulatory Insights

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

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

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

ASEAN MDD

Uncategorized / December 16, 2024 / atonu dutta / Medical device, Medical Device Consultants in India, Medical Device Regulatory Affairs, Medical Device Regulatory Consultant, Medical Device Regulatory Consulting, Regulatory Consultant

Medical Device Regulatory Affairs, Regulatory Consultant, Medical Device Regulatory Consulting,

The Association of South East Asian Nations (ASEAN) is a regional bloc composed of ten countries: Brunei Darussalam, Burma, Cambodia,

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UncategorizedMedical device, Medical Device Consultants in India, Medical Device Regulatory Affairs, Medical Device Regulatory Consultant, Medical Device Regulatory Consulting, Regulatory Consultant

Sterilization of Medical Devices

Uncategorized / December 9, 2024 / atonu dutta / Med Device Quality Consulting, Medical Device Consultant, Medical device consulting in India, Medical Device Regulatory Affairs, Medical Device Regulatory Consultant

Medical Devices Consultant, Medical Device Regulatory Consultant, Medical device consulting in India,

Medical device sterilization is essential to maintain the safety of patients and healthcare professionals. Improperly sterilized medical devices can produce

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UncategorizedMed Device Quality Consulting, Medical Device Consultant, Medical device consulting in India, Medical Device Regulatory Affairs, Medical Device Regulatory Consultant

Applying Usability Engineering to Medical Devices

Uncategorized / December 9, 2024 / sanikakulkarni / Medical device consulting companies in India, Medical device consulting services, Medical Device Regulatory Consultant, Medical Device Regulatory Consultants in India, Medical Device Regulatory Consulting, medical devices, Regulatory Consultant

Medical Devices, Regulatory Consultant, Medical Device Regulatory Consultants in India,

Usability engineering for medical devices, or human factors engineering, is a concept of understanding interactions between the user and the

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UncategorizedMedical device consulting companies in India, Medical device consulting services, Medical Device Regulatory Consultant, Medical Device Regulatory Consultants in India, Medical Device Regulatory Consulting, medical devices, Regulatory Consultant

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