New Developments in FDA Regulation of AI have been announced on Tuesday that it is developing a framework for regulating artificial intelligence products used in medicine that continually adapt based on new data. Artificial intelligence (“AI”) can be broadly defined as a device or product that can imitate intelligent behavior. In the health care space, […]
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Medical device packaging importance states the packaging of medical devices frequently takes place in a clean room, and the packaged devices normally undergo some kind of sterilization. But it is the role of packaging to keep the device sterile right up until use. The correct selection of packaging, therefore, is a crucial but complex decision,
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Benefits of FDA 21 CFR Part 11 provide an opportunity for medical device companies to reap the organizational advantages of paperless record-keeping systems. It also helps the FDA ensure that when medical device companies use electronic record-keeping systems, that document security and authenticity are adequately maintained. The regulation sets out a framework for properly managing digital records so
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CE Mark for Medical Devices: An Overview CE marking is essential for medical device manufacturers aiming to enter the European market. While the process may seem daunting, with the right guidance, it can be navigated smoothly. This comprehensive guide will walk you through the steps of obtaining CE marking for your medical devices, ensuring compliance
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How Medical Gloves Are Manufactured: A Step-by-Step Guide Medical gloves are vital tools in infection control, acting as a protective barrier between healthcare providers and patients. Whether used in surgeries, examinations, or laboratory settings, these gloves must meet stringent quality and regulatory standards to ensure safety and hygiene. In this detailed guide, we walk you
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Introduction Intraocular lenses manufacturing is a critical process for producing high-quality IOLs used in cataract and vision correction surgeries. With increasing global demand due to aging populations and rising cataract cases, entering the IOL market offers significant opportunities for startups and established medical device manufacturers. This guide covers the entire IOL manufacturing process, plant setup,
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IV Set Overview: IV sets are critical medical devices used to administer fluids and medications directly into a patient’s vein. They are indispensable in treating conditions such as dehydration, electrolyte imbalances, drug delivery, and blood transfusions. With demand steadily rising, the manufacturing of IV sets requires precision, compliance, and advanced technology. Introduction to IV Set
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Overview of Catheter Manufacturing Catheter manufacturing has evolved from basic tubes to highly specialized devices tailored for specific medical applications, including pulmonary, cardiac, neonatal, and epidural uses. Today’s catheters may also accommodate tissue ablation, monitoring, or drug delivery. Minimum production for a catheter manufacturing unit: ~1,200 units to break even. Regulatory compliance: Adherence to FDA
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CDSCO Application process of India’s Central Drugs Standard Control Organization (CDSCO) has published several notices since mid-March in response to the ongoing pandemic. These address new measures to expedite access to devices intended to prevent or treat COVID-19, to safeguard supply of other critical IVDs, and to reduce the exposure of CDSCO staff to the
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Operon Strategist specializes in guiding companies through the complex process of obtaining a CDSCO manufacturing license for In-Vitro Diagnostic (IVD) devices. With a deep understanding of regulatory requirements and years of industry experience, Operon Strategist provides comprehensive support, from documentation preparation to liaising with regulatory bodies. Our expert team ensures a smooth, efficient path to
