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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

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

Post-Market Surveillance Requirements for Medical Devices in JAPAN

Uncategorized / March 3, 2025 / sanikakulkarni / Medical Device Consultancy, Medical Device Consultants in India, Medical device consulting services, Medical Device Regulatory Consultants in India, Medtech Consulting, Post-Market Surveillance

Post-Market Surveillance, Medical Device Consultancy, Medtech Consulting, Risk Management, PMDA,

The Pharmaceutical and Medical Device Act (PMD Act) governs medical devices in Japan, which sets the requirements for pre-market approval

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UncategorizedMedical Device Consultancy, Medical Device Consultants in India, Medical device consulting services, Medical Device Regulatory Consultants in India, Medtech Consulting, Post-Market Surveillance

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

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

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

Medtech Regulatory, Medtech Consulting, Medical Device Regulatory Affairs, 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

STATISTICS 101: TYPES OF DATA

Uncategorized / December 17, 2024 / atonu dutta / Med Device Quality Consulting, Medical Device Consultant, Medical Device Regulatory Affairs Consultant near me, Medical Device Regulatory Consultants in India, Medtech Consulting, Statistics, Types of Data

Statistics, Types of Data, Medtech Consulting, Medical Device Consultant, Med Device Quality Consulting,

An understanding of statistics is useful whenever you are anaylsing any types of data and want to take actions based

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UncategorizedMed Device Quality Consulting, Medical Device Consultant, Medical Device Regulatory Affairs Consultant near me, Medical Device Regulatory Consultants in India, Medtech Consulting, Statistics, Types of Data

STATISTICS 101: TYPES OF DISTRIBUTIONS

Uncategorized / December 17, 2024 / atonu dutta

In the last blog, we talked about different types of data. Data, as we know, can be discrete or continuous.

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WHO Prequalification of In-Vitro diagnostics

Uncategorized / December 17, 2024 / atonu dutta / FDA guidelines for medical devices PDF, In Vitro diagnostics, Med Device Quality Consulting, Medtech Consulting, Pharma Regulatory Consulting Firms, Regulatory Consultant, who

In Vitro diagnostics, who, Med Device Quality Consulting, Regulatory Consultant,

WHO PQ: What, How, and WHY? The World Health Organisation Prequalification (WHO PQ) programme helps countries with low and medium-level

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UncategorizedFDA guidelines for medical devices PDF, In Vitro diagnostics, Med Device Quality Consulting, Medtech Consulting, Pharma Regulatory Consulting Firms, Regulatory Consultant, who

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

REPROCESSING OF REUSABLE MEDICAL DEVICES: INTRODUCTION Read More »

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

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

Blog on Biomaterials Read More »

UncategorizedBiomaterials, Med Device Quality Consulting, Medical Device Consultancy, Medical Device Manufacturing Consultant, Medical Device Regulatory Consultant, 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

GOOD DOCUMENTATION PRACTICES

Uncategorized / December 16, 2024 / atonu dutta / Med Device Quality Consulting, Medtech Consulting, Quality Assurance Consultation, Quality Assurance Consulting, Quality Assurance Consulting for Medical Devices, Quality Management System

Quality Management System, Med Device Quality Consulting, Quality Assurance Consulting, Medtech Consulting,

Good Documentation Practices (GDP) serve as the foundational elements of a robust Quality Management System. Mandated by numerous regulatory bodies,

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UncategorizedMed Device Quality Consulting, Medtech Consulting, Quality Assurance Consultation, Quality Assurance Consulting, Quality Assurance Consulting for Medical Devices, Quality Management System

AN INTRODUCTION TO MEASUREMENT SYSTEM ANALYSIS

Uncategorized / December 16, 2024 / atonu dutta / Measurement System Analysis, Medical Device Regulatory Affairs, Medical Device Regulatory Affairs Consultant, Medical Device Regulatory Affairs in India, Regulatory Affairs Agency, Regulatory Affairs Consultants, Regulatory Affairs Consulting

Measurement System Analysis, Regulatory Affairs Consultants, Regulatory Affairs Agency,

Measuring instruments and measurement systems are at the core of any manufacturing industry. The goal of every organisation that strives

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UncategorizedMeasurement System Analysis, Medical Device Regulatory Affairs, Medical Device Regulatory Affairs Consultant, Medical Device Regulatory Affairs in India, Regulatory Affairs Agency, Regulatory Affairs Consultants, Regulatory Affairs Consulting

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

Understanding the ISO 80369 Standards for Medical Connectors

Uncategorized / December 16, 2024 / atonu dutta / Clinical Quality Assurance Consultant, ISO 80369, Med Device Quality Consulting, Quality Assurance Consultant, Quality Assurance Consultation, Quality Assurance Consulting, Quality Assurance Consulting Firms, Quality Assurance Consulting for Medical Devices in India

ISO 80369, Quality Assurance Consultant, Quality Assurance Consulting Firms,

Small-bore connectors, which have an opening size of less than 8.5 mm, are essential components in various medical devices used

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UncategorizedClinical Quality Assurance Consultant, ISO 80369, Med Device Quality Consulting, Quality Assurance Consultant, Quality Assurance Consultation, Quality Assurance Consulting, Quality Assurance Consulting Firms, Quality Assurance Consulting for Medical Devices in India

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

Usability-Evaluation-of-Aseptic-Presentation

Uncategorized / December 16, 2024 / atonu dutta

evaluation, Medical Device Consultant, Medical Device Consultancy, Medical device consulting,

Aseptic presentation plays a crucial role in ensuring patient safety and preventing infections in healthcare settings. Proper packaging and presentation

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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

HOW TO PERFORM USER RESEARCH?

Uncategorized / December 16, 2024 / atonu dutta

Medical Device Consultancy, User Research, Medtech Consultant, Medical device consulting in India,

Hello readers! We’re back (after quite some time, yeah!) with a long-due update on methods of user research. This is

HOW TO PERFORM USER RESEARCH? Read More »

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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

National Policy in R&D and Innovation

Uncategorized / December 16, 2024 / atonu dutta / Medical Device Regulatory Affairs Consultant, Medical Device Regulatory Affairs in India, R&D, R&D and Innovation, Regulatory Affairs Agency, Regulatory Affairs Consultancy, Regulatory Affairs Consultants

R&D, R&D and Innovation, Regulatory Affairs Consultants, Regulatory Affairs Agency,

India takes pride for being known as ‘Pharmacy of the world’. The country has made it possible by becoming one

National Policy in R&D and Innovation Read More »

UncategorizedMedical Device Regulatory Affairs Consultant, Medical Device Regulatory Affairs in India, R&D, R&D and Innovation, Regulatory Affairs Agency, Regulatory Affairs Consultancy, Regulatory Affairs Consultants

HOW TO CREATE A DESIGN HISTORY FILE FROM SCRATCH!

Uncategorized / December 16, 2024 / atonu dutta

DHF, Design History File, Regulatory Affairs Consulting, Regulatory Affairs Agency,

What is a Design History File (DHF)? The design history file is a compilation of records that describes the design

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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.

eSTAR Program: Revolutionizing FDA Regulatory Process Read More »

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,

Asean mdd Read More »

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

ISO 10993ISOISO 10993-23:2021 – Biological evaluation of medical devices – Part 23: Test for irritationISO 10993ISO

Uncategorized / December 16, 2024 / atonu dutta / biological evaluation, Clinical Quality Assurance Consultant, Med Device Quality Consulting, Quality Assurance Consultant, Quality Assurance Consultation, Quality Assurance Consulting, Quality Assurance Consulting for Medical Devices in India

biological evaluation, Quality Assurance Consultant, Quality Assurance Consultation, QA consulting,

The safety of biological evaluation is one important piece of the puzzle to demonstrate the safety of a medical device.

ISO 10993ISOISO 10993-23:2021 – Biological evaluation of medical devices – Part 23: Test for irritationISO 10993ISO Read More »

Uncategorizedbiological evaluation, Clinical Quality Assurance Consultant, Med Device Quality Consulting, Quality Assurance Consultant, Quality Assurance Consultation, Quality Assurance Consulting, Quality Assurance Consulting for Medical Devices in India

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

HISTORY OF MEDICAL DEVICES REGULATION IN THE USA Read More »

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

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

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