Author: ELT Team

What is a Risk Management File?

Ensuring the safety and efficacy of medical devices is crucial for protecting patients and meeting regulatory standards. A Risk Management File plays

Manufacturing License Risk Management ISO 14971

Manufacturing License Risk Management ISO 14971 refers to the process of ensuring safety and profitability by managing risks related to medical devices.

How To Apply for Loan License?

Let me explain the process apply for loan license. It is straightforward. A loan license allows you to manufacture products using someone

What Is The CDSCO Registration Process?

The Central Drugs Standard Control Organization (CDSCO) is India’s national regulatory authority for drugs and medical devices. Under the Ministry of Health

Innovative Devices for Clinical Trial Form MD-28 New IVD

The Innovative Devices for Clinical Trial Form MD-28 is an important document for devices that are discovered and newly introduced to the

What Does Schedule Fourth of MDR 2017 Include?

This article, Schedule Fourth of MDR 2017, provides a list of comprehensive documents required for Schedule Fourth Medical Devices Rules (MDR) 2017.

What Is Premarket Approval?

The FDA, also known as the Food and Drug Administration, uses Premarket Approval to ensure that class III MDRs are effective or

What Is The Form 44 In CDSCO?

In simple words, form 44 in CDSCO takes permission to import or manufacture new pharmaceuticals to conduct medical trials. This article covers

What Is A Drug License?

This question is widely asked: what is a Drug License, and is it the most straightforward term to know what it means?

What Is The Ethics Committee For Clinical Trial

Many people are unfamiliar with the Ethics Committee for Clinical Trials. The Ethics Committee reviews and ensures that human medical device research