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ISO 17665 Sterlization of Health Care Products

ISO 17665 Sterilization of Health Care Products

Sterilization is the backbone of safe healthcare practices, ensuring that medical devices are free from harmful microorganisms like bacteria, viruses, and fungi.

What Is Good Clinical Practice? [Everything About GCP]

Do you know what Good Clinical Practice is? It is a group of standards that ensures clinical trials are conducted reliably, safely,

What Regulation Apply To Medical Device Packaging

What Regulations Apply To Medical Device Packaging?

When you manufacture, import or purchase medical devices, have you ever focused on their functionality, design, or the technology they use? Do

ISO 11607 – Packaging for Terminally Sterilized Medical Devices

In the global world of medical devices, packaging plays a major role in making sure that the safety and effectiveness of the

What Is ISO 15189 And Why Is It Important?

Imagine your medical test results that are wrong. It could to misdiagnosis, delayed treatment, or unnecessary stress. So to avoid all these

What is BS ISO 7101? [Healthcare Organization Management]

Imagine you are running a business where every tiny detail matters – If YES you must understand “How safely products are made

What are the Requirements of ISO 13485?

ISO 13485 is an international standard identifying the need for a quality management system (QMS) specifically for the medical device industry. It

What are the ISO Standards for Medical Devices?

ISO standards play an essential role in the medical device industry by ensuring that all the products are safe, reliable, and fulfil

What is Post-Market Surveillance in ISO 13485?

ISO 13485 is the quality management system that maintains the quality of medical devices in India. So, if you are dealing with

Integral CDSCO License for Self-Testing IVDs in India

Navigating the landscape of medical regulation can be haunting, especially for those interested in self-testing IVD diagnostics in India. The interval of

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.