sanikakulkarni

Understanding CMR and Endocrine-Disrupting Substances in Medical Devices

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

Understanding CMR and Endocrine-Disrupting Substances in Medical Devices Read More »

Uncategorized, , , , ,

MedTech Regulatory Insights May 2025

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

MedTech Regulatory Insights May 2025 Read More »

Uncategorized, , , ,

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

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

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

Uncategorized, , ,

Water in Medical Device Manufacturing: Types, Uses & Standards

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 Hâ‚‚O in the medical device world.

Water in Medical Device Manufacturing: Types, Uses & Standards Read More »

Uncategorized, , ,

MedTech Regulatory Insights March 2025

EMA INTRODUCES REGULAR SCIENTIFIC ADVICE PROCESS FOR HIGH-RISK MEDICAL DEVICES On January 17, 2025, the European Medicines Agency (EMA) published

MedTech Regulatory Insights March 2025 Read More »

Uncategorized, , , , ,

Post-Market Surveillance Requirements for Medical Devices in JAPAN

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

Post-Market Surveillance Requirements for Medical Devices in JAPAN Read More »

Uncategorized, , , , ,

MedTech Regulatory Insights January 2025

On 16 October 2024, the Medical Device Coordination Group (MDCG) published the revised guidance titled “Application of MDR Requirements to

MedTech Regulatory Insights January 2025 Read More »

Uncategorized, , , , ,

How to Write an Intended Use for a Medical Device?

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 »

Uncategorized, , , , , , , , ,

Applying Usability Engineering to Medical Devices

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

Applying Usability Engineering to Medical Devices Read More »

Uncategorized, , , , , ,

Make-in-India for Medical Devices: Is There Support?

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,

Make-in-India for Medical Devices: Is There Support? Read More »

Uncategorized, , , , , , ,

Advantages of an eQMS Software

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

Advantages of an eQMS Software Read More »

Uncategorized, , , , , ,
×