Access to De Novo Summaries – A treasure for manufacturers

The De Novo pathway by the US Food and Drug Administration (FDA), is a risk-based classification process to classify novel medical devices for which there are no legally marketed predicate devic...

17 years Journey – Surgical Mesh for Transvaginal Repair of Pelvic Organ Prolapse (POP)

While the preamendment devices can serve as excellent predicate devices, there are practical challenges associated while using such devices for approvals. One such example is that of a surgical ...

CLIA Database: A Centralized Database of Clinical Tests & Instruments

Diagnosis plays a vital role in curing a disease. If the diagnosis itself is wrong, the disease cannot be treated. Osteosarcoma, a dangerous but common form of bone cancer which mostly affects t...

De Novo paving the path for Technological Advancements

While there existed many computerized and digital tomographs with specific applications (Trauma CT, Cardiac CT, CT used in Nuclear Medicine / PET), there has never been one with an application i...

The Harmonized ISO 13485 – A Brief Insight!

Can you imagine using life-saving medical devices that have not been certified for quality, safety and efficacy?

These aspects if compromised, can result in enormous adverse effects and a...

Quality Sytems: Facilitating continuous improvement!

What is continuous improvement and how can we achieve it? An answer to this is a premeditated and well-implemented quality management system (QMS).

A QMS, in simple words, is a system in ...

IEC 60601-1 Evolution of Electrical Safety standards to match Device Development

Standards are considered an integral part of product design and development. Standards are very important in medical device applications. Some of the most critical standards exist in the medical...

Document Control System: The Core of Quality Management System

Has managing documents always been a tedious and time consuming task for you? Have you faced issues of cost drain and compliance while maintaining the documents for medical devices?  We und...

FDA – Medical Devices Advisory Committee

The U.S. Food and Drug Administration (FDA) has 31 advisory committees responsible for the evaluation and regulation of drugs, medical devices, and biologics. The advisory committee protects and...

IMPORT/EXPORT-U S: Expand your boundaries

Globalization and international trade has drastically changed the face of the world. In the last couple of years, communication and trade has bloomed between the developed and developing countri...