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Mastering the Clinical Evaluation Report (CER)

Uncategorized / May 28, 2025 / sanikakulkarni / CE, CER, Clinical Evaluation, Clinical Evaluation Report

Clinical Evaluation, Clinical Evaluation Report, CER, CE,

Mastering the Clinical Evaluation Report (CER) In our last post, we explored “Common Pitfalls in Clinical Evaluation Reports – Avoid […]

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UncategorizedCE, CER, Clinical Evaluation, Clinical Evaluation Report

Understanding CMR and Endocrine-Disrupting Substances in Medical Devices

Uncategorized / May 13, 2025 / sanikakulkarni / Carcinogenic, CMR, CMR Substances, medical devices, Mutagenic, Reprotoxic chemicals

CMR, Medical Devices, CMR Substances, Carcinogenic, Mutagenic, Reprotoxic chemicals,

A Quick Overview of CMR With growing focus on patient safety and environmental health, the use of hazardous substances like

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UncategorizedCarcinogenic, CMR, CMR Substances, medical devices, Mutagenic, Reprotoxic chemicals

Root Cause Analysis: The 5-Why Technique

Uncategorized / May 8, 2025 / sanikakulkarni / 5 why technique, five whys Root Cause Analysis, Root Cause Analysis, Root Cause Analysis 5 whys

Root Cause Analysis, five whys Root Cause Analysis, Root Cause Analysis 5 whys, 5 why technique,

While analysing issues such as defects, customer complaints and non-conformances, identifying the root cause of the problem and taking effective

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Uncategorized5 why technique, five whys Root Cause Analysis, Root Cause Analysis, Root Cause Analysis 5 whys

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

Building Our QA System: A Journey from Chaos to Clarity

Uncategorized / April 30, 2025 / sanikakulkarni / QA, QA System, Quality Assuarance, Quality Assurance Consulting, Risk Management, Training

QA System, Quality Assuarance, Training, Risk Management, QA, Quality Assurance Consulting,

Building Our QA System: A Journey from Chaos to Clarity We’re a consulting team, working behind the scenes with clients,

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UncategorizedQA, QA System, Quality Assuarance, Quality Assurance Consulting, Risk Management, Training

Entering China’s Booming Healthcare Market: Regulatory Roadmap and the Challenges

Uncategorized / April 29, 2025 / sanikakulkarni / FDA Medical Device Registration, Medical Device Product Registration, Medical Device Registration, US FDA Medical device Registration

Medical Device Registration, FDA Medical Device Registration, US FDA Medical device Registration, Medical Device Product Registration,

Entering China’s Booming Healthcare Market: Regulatory Roadmap and the Challenges. Why CHINA? China’s $170 billion medical device market (projected by

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UncategorizedFDA Medical Device Registration, Medical Device Product Registration, Medical Device Registration, US FDA Medical device Registration

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

Registration of Medical Devices in Brazil

Uncategorized / April 7, 2025 / sanikakulkarni

ANVISA, which stands for Agência Nacional de Vigilância Sanitária, is Brazil’s National Health Surveillance Website: The official ANVISA website is

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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

How to Import Your Medical Device into India

Uncategorized / April 3, 2025 / sanikakulkarni

What is an Import License? An import license is an official permit issued by a regulatory authority that allows an

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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

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

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

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

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 Distribution

Uncategorized / December 17, 2024 / sanikakulkarni

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

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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

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

STATISTICS 101: Normal Distribution

Uncategorized / December 17, 2024 / atonu dutta

In the last blog, we discussed different types of distributions. The Normal Distribution is one of the most important. Its

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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

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

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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

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