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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

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

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

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

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

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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