Medical device - Alceon Medtech Consulting

MedTech Regulatory Insights May 2025

Uncategorized / May 6, 2025 / sanikakulkarni / Medical device, Medical Device Consultancy, Medtech Consultant, Medtech Consulting, Medtech Regulatory

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

Regulatory Radar Australia Enforces UDI Regulations – New Era for Device Traceability Begins Australia’s Unique Device Identification (UDI) regulations are […]

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

Water in Medical Device Manufacturing: Types, Uses & Standards

Uncategorized / April 28, 2025 / sanikakulkarni / manufacturing for medical devices, Medical device, medical device manufacture, medical device manufacturing

medical device manufacturing, manufacturing for medical devices, medical device manufacturing, medical device manufacture,

Water in Medical Device Manufacturing: Types, Uses & Standards Water is more than just H₂O in the medical device world.

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Uncategorizedmanufacturing for medical devices, Medical device, medical device manufacture, medical device manufacturing

MedTech Regulatory Insights April 2025

Uncategorized / April 5, 2025 / sanikakulkarni / Medical device, Medical Device Consultancy, Medtech Consultant, Medtech Consulting, Medtech Regulatory

AI vs. Human Judgment: Spectral AI’s DeepView® System Proves Superior in Burn Care A new AI-driven technology is set to

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

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

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

Reprocessing of Reusable Medical Devices: Introduction

Uncategorized / December 17, 2024 / atonu dutta / Medical device, Medical Device Consultancy, Medical Device Consultant, Medical device consulting services, Medical Device Manufacturing Consultant, Medical Device Regulatory Consulting, medical devices, Medtech Consultant

Medical device, Medical devices, Medical Device Consultant, Medical Device Consultancy,

Hello readers! We are launching another blog series on reprocessing of reusable medical devices. The idea is to serve you

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UncategorizedMedical device, Medical Device Consultancy, Medical Device Consultant, Medical device consulting services, Medical Device Manufacturing Consultant, Medical Device Regulatory Consulting, medical devices, Medtech Consultant

Reprocessing of Reusable Medical Devices: Worst-Case Selection

Uncategorized / December 16, 2024 / atonu dutta / Medical device, Medical Device Consultancy, Medical Device Consultants in India, Medical device consulting companies in India, Medical device consulting in India, Medical device consulting services, Medical Device Regulatory Consulting, medical devices

Medical Device Consultants in India, Medical device consulting service, Medical Device Consultancy,

All right, we’re back with more content on reprocessing of reusable medical devices. We introduced this topic in our last

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

Clinical Evaluation of Medical Devices III

Uncategorized / December 16, 2024 / atonu dutta / Medical device, Medical Device Consultancy, Medical Device Consultant, Medical Device Consultants in India, Medical device consulting in India, Medical device consulting services, Medical Device Manufacturing Consultant, Medical Device Regulatory Consulting, medical devices

Medical Devices, Medical device consulting, Medical Device Consultancy, Medical Device Consultant,

Hello and welcome to another brainstorming blog to discuss the clinical evaluation of medical devices! In our previous blog post,

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

How to Write an Intended Use for a Medical Device?

Uncategorized / December 16, 2024 / sanikakulkarni / FDA guidelines for medical devices, FDA Regulatory Consulting Firms, Medical device, Medical Device Consultancy, Medical Device Consultant, Medical device consulting companies in India, Medical device intended use, Medical Device Regulatory Consultants in India, Medical Device Regulatory Consulting, Medtech Consultant

Medical Device, FDA Regulatory Consulting Firms, Medtech Consultants, Medical Device Consultants,

Hello readers, we’re back with another topic in the series of Usability Engineering for Medical Device. The last blog described

How to Write an Intended Use for a Medical Device? Read More »

UncategorizedFDA guidelines for medical devices, FDA Regulatory Consulting Firms, Medical device, Medical Device Consultancy, Medical Device Consultant, Medical device consulting companies in India, Medical device intended use, Medical Device Regulatory Consultants in India, Medical Device Regulatory Consulting, Medtech Consultant

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

Medical Device Usability Engineering: Using Specifications

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

Medical Device, Medical device consulting in India, Medical Device Consultants in India,

Our last blog in the series of Usability Engineering for Medical Device highlighted mandatory steps of the usability process. It

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

History of Medical Devices Regulation in the USA

Uncategorized / December 16, 2024 / atonu dutta / Medical device, Medical Device Consultancy, Medical Device Consultant, Medical device consulting services

Medical device, Medical device consulting services, Medical Devices, Medical Device Consultancy,

In the first part of this series on medical device regulation in the USA, we are discussing the chronology of

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UncategorizedMedical device, Medical Device Consultancy, Medical Device Consultant, Medical device consulting services

Do We Need PMCF Every Time for Every Device?

Uncategorized / December 9, 2024 / sanikakulkarni / Medical device, Medical Device Consultancy, Medical device consulting companies in India, Medical device consulting in India, Medical device consulting services, Medical Device Regulatory Consultants in India, Medtech Consultant, PMCF, post market clinical follow up

PMCF, Medical Device, Medical device consulting services, Post Market Clinical Follow up,

Cath Solutions Inc. recently got a CE mark and is keen to start selling. While trying to register with the

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UncategorizedMedical device, Medical Device Consultancy, Medical device consulting companies in India, Medical device consulting in India, Medical device consulting services, Medical Device Regulatory Consultants in India, Medtech Consultant, PMCF, post market clinical follow up

Clinical Evaluation of Medical Device – Part II

Uncategorized / December 9, 2024 / apurva / CE for Medical Device, Clinical Evaluation, Medical device, Medical Device Consultancy, Medical Device Consultant, Medical Device Consultants in India, Medical device consulting in India, Medical device consulting services, Medical Device Regulatory Consultants in India, Medical Device Regulatory Consulting

Medical Device, Clinical Evaluation, CE for Medical Device, Medical device consulting services,

Welcome back, everyone! We hope your medical devices are performing well and meeting the necessary approval standards. If you require

Clinical Evaluation of Medical Device – Part II Read More »

UncategorizedCE for Medical Device, Clinical Evaluation, Medical device, Medical Device Consultancy, Medical Device Consultant, Medical Device Consultants in India, Medical device consulting in India, Medical device consulting services, Medical Device Regulatory Consultants in India, Medical Device Regulatory 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