sanikakulkarni - Alceon Medtech Consulting

New EU Green Rules Are Coming – Are Medical Device Manufacturers Ready?

Uncategorized / June 30, 2025 / sanikakulkarni / CE, CER, Clinical Evaluation, Clinical Evaluation Report

New EU Green Rules Are Coming – Are Medical Device Manufacturers Ready? As the EU accelerates its push toward a […]

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UncategorizedCE, CER, Clinical Evaluation, Clinical Evaluation Report

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