Author: ELT Team

What is a Clinical Evaluation Report (CER) For Medical Device?

So, if you are struggling with confusion about a Clinical Evaluation Report, here is your answer. It is a technical document designed

Medical Device Reporting (MDR)

Medical Device Reporting (MDR) plays a crucial role in ensuring the safety and effectiveness of medical devices in healthcare settings. Enforced by

What Is Investigational Device Exemption (IDE)?

If you are confused and searching for the answer of what Investigational Device Exemption is, so basically is widely known as an

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 as per 14971

If you are eager to know what Manufacturing License Risk Management is as per 14971, here is the detailed answer to your

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