Medical Device Regulatory Consulting - Alceon Medtech Consulting

MedTech Regulatory Insights Feb 2025

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

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

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

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

An introduction to the IEC 60601 standard.

Uncategorized / December 16, 2024 / atonu dutta / IEC 60601, Medical Device Consultant, Medical Device Consultants in India, Medical device consulting services, Medical Device Manufacturing Consultant, Medical Device Regulatory Consulting, Medtech Consultant

IEC 60601, Medical Device Consultant, Medtech Consultant , Medical Device Consultants in India,

Medical devices powered by electricity offer life-saving capabilities, yet they also present risks, especially when invasive procedures bypass the body’s

An introduction to the IEC 60601 standard. Read More »

UncategorizedIEC 60601, Medical Device Consultant, Medical Device Consultants in India, Medical device consulting services, Medical Device Manufacturing Consultant, Medical Device Regulatory Consulting, Medtech Consultant

COMPLIANCE WITH ELECTRONIC IFUs

Uncategorized / December 16, 2024 / atonu dutta / Electronic IFU, EU MDR, Medical Device Regulatory Consulting, Pharma Regulatory Consulting Firms, Regulatory Affairs Agency, Regulatory Affairs Consultancy, Regulatory Consultant

EU MDR, Electronic IFU, Regulatory Consultant, Regulatory Affairs Consultancy, Regulatory Affairs Agency,

Practical Guide Well, in our previous blog on electronic IFUs, we discussed that e-IFU requirements are not mandatory to comply

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UncategorizedElectronic IFU, EU MDR, Medical Device Regulatory Consulting, Pharma Regulatory Consulting Firms, Regulatory Affairs Agency, Regulatory Affairs Consultancy, Regulatory Consultant

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

eSTAR Program: Revolutionizing FDA Regulatory Process

Uncategorized / December 16, 2024 / atonu dutta / estar, Estar Program, FDA, FDA regulatory process, Medical device consulting services, Medical Device Regulatory Consulting, Regulatory Affairs Consultants

estar, fda, estar program, Regulatory Affairs Consultants, Medical Device Regulatory Consulting,

In the ever-changing landscape of medical device regulation, technology plays a vital role in improving efficiency and ensuring robust processes.

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Uncategorizedestar, Estar Program, FDA, FDA regulatory process, Medical device consulting services, Medical Device Regulatory Consulting, Regulatory Affairs Consultants

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

Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission

Uncategorized / December 13, 2024 / atonu dutta / 510 k, How to become a medical device consultant, Medical Device Consultancy, Medical Device Consultants in India, Medical device consulting services, Medical Device Regulatory Consulting, medical devices

510 k, Medical Devices, Medical Device Consultants in India, Medical Device Regulatory Consulting,

USFDA (United States Food and Drug Administration) regulates medical devices in the USA. According to USFDA, medical devices are classified

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Uncategorized510 k, How to become a medical device consultant, Medical Device Consultancy, Medical Device Consultants in India, Medical device consulting services, Medical Device Regulatory Consulting, medical devices

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

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

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