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Demand of Medical Devices

Demand of Medical Devices in Indian Healthcare sector

The demand for medical devices in India has been permitted by 100 % FDI by means of programmed courses in

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Notified Body

Selection of a Notified Body and Their Process for your new device authority

Notified Bodies an overview: You must have your device CE marked before you may market it in the European Union.

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FDA 21 CFR Part 820 and ISO 13485

Difference Between FDA 21 CFR Part 820 and ISO 13485

Over the course of more than 20 years in regulatory affairs and quality consistency, we’ve discovered how difficult it can

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Quality and Regulatory Affairs of Medical Device

Exploring Quality and Regulatory Affairs in Medical Devices

Introduction Quality and Regulatory Affairs is a profession that came from governments’ desire to protect public health by ensuring the

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FDA 510(k) Approval

Guide to Navigating US FDA 510(k) Approval for IVDs (In Vitro Diagnostic Devices)

Introduction In the ever-evolving landscape of medical device regulation, obtaining approval for In Vitro Diagnostic Devices (IVDs) can be a

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Medical Device Sterilization

A Guide to Medical Device Sterilization Methods

When it comes to medical devices, safety and hygiene are of most importance. Ensuring that medical devices are free from

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Post Market Clinical Follow

Post Market Clinical Follow Up

Post Market Clinical Follow (PMCF) up is an effective method that constantly helps to monitor the clinical evaluation results. This

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Clinical Evaluation Report

Understanding the Clinical Evaluation Report

Key Aspects of Clinical Evaluation Reports (CERS) in Devices: A Clinical examination Report (CER) documents the findings from a clinical

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SFDA regulations on MDMA

SFDA Regulations on MDMA: Significant and Non-significant Changes Explained

SFDA Issues Guidance Document on MDMA The Saudi Food and Drug Authority (SFDA) recently released a guidance document to clarify

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UCMPMD Guidelines

UCMPMD Guidelines: How to File Self-Declaration & Marketing Expenditure Disclosure

If you’re part of the medical device industry in India, you’ve likely come across the term UCMPMD Guidelines. These guidelines

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