ELT Team, Author at Medical Device Registration | CDSCO Certificate Consultancy

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

Are you a medical device manufacturer or distributor looking to enter a foreign market? You’ve probably heard about the Clinical Evaluation Report

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)?

Any clinical investigation, including pilot, pivotal, and first-in-human studies, needs an Investigational Device Exemption (IDE) in accordance with India’s Medical Device Rules,

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

ELT Corporate Private Limited is a legal consulting firm specializing in medical device regulations. We offer services related to Medical Device Rules 2017, including documentation preparation and guidance on scientific, legal, and technical requirements.