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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PATIENT PREFERENCE INFORMATION- THE TWITTER OF FDA (STREAMLINING PATIENT FEEDBACKS)
Patient inputs have always remained the core for healthcare systems, healthcare professionals & medical equipment manufacturers. Especially in the age of social…
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CYBERSECURITY – Don’t Neglect. An increasing threat of the modern world
Rita, a nurse at PCN Health Care Hospital logged into her system on a Monday morning to retrieve a patient’s record and…
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Software Precertification Program: An Innovative Approach to Expedite Patient Access for SaMD
The Software Precertification (Pre-Cert) Program is a pathway that comprises a regulatory model which is more visible than the current model to…
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Are Breast Implants Safe?
In recent times, there has been a growing concern related to the safety of breast implants. Breast implant-associated anaplastic large cell lymphoma…
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Is EU-MDR coming later?
EU MDD to MDR – A major change Medical Device Directive (MDD) which is in action now and will shortly be superseded…
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