Medical device consulting in India - Alceon Medtech Consulting

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

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

ARE YOU READY TO MOVE TO ELECTRONIC IFUs?

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

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

Are you one of those who thinks uploading instructions for use (IFU) on the website is enough to meet the

ARE YOU READY TO MOVE TO ELECTRONIC IFUs? Read More »

UncategorizedIFUs, Medical Device Consultancy, Medical device consulting in India, 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

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

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

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

Do we need PMCF every time for every device? Read More »

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

Make-in-India forMedical Devices:Is there a support?

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

Medical devices, Medical Device Manufacturing Consultant, Medical device consulting services,

The previous blog on Make-in-India set an understanding for our readers about how the Indian medical devices market is growing,

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

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

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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

Medical Devices: Is Make in India effective?

Uncategorized / December 9, 2024 / atonu dutta / make in india, Medical Device Consultancy, Medical device consulting companies in India, Medical device consulting in India, Medical Device Market, Medical Device Policy, Medical Device Regulatory Consultants in India, medical devices

Medical Devices, Medical Device Market, Medical Device Policy, make in india, Medtech Consultant ,

Since the announcement of Make in India in the year 2014, the medical device industry has grown significantly. The Indian

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Uncategorizedmake in india, Medical Device Consultancy, Medical device consulting companies in India, Medical device consulting in India, Medical Device Market, Medical Device Policy, Medical Device Regulatory Consultants in India, medical devices

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

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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