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…
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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…
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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),…
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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…
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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…
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IEC 60601-1 Evolution of Electrical Safety standards to match Device Development
Standards are considered an integral part of product design & development. Standards are very important in medical device applications. Some of the…
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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…
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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…
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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…
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