Postmarket Surveillance: An inescapable sound of noise
Are you a Medical Device Manufacturer? an employee of a medical device company? Or perhaps someone with an interest in Medical Devices.…
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Product Development
Many companies treat product development as if it is equivalent to manufacturing. In reality, the two are tremendously different. In the arena…
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Addressing Duodenoscope contamination – An FDA Initiative
While reusable devices significantly help in cost-cutting and optimization of hospital supplies; cross-contamination is a prevalent problem with these devices. Regulatory bodies…
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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…
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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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