Operon Strategist – Page 18 – Operon Strategist

USFDA Releases New Guidance on AI in Medical Products

Incorporating Artificial Intelligence into Medical Products: The FDA’s Strategy On March 15, the U.S. Food and Drug Administration (FDA) released a comprehensive paper titled “Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together.” This document outlines the FDA’s strategy for integrating artificial intelligence (AI) into medical products across its various […]

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Mandatory BIS Certification for Medical Textile Products: Ensuring Compliance and Quality

Mandatory BIS Certification for Medical Textile Products The Bureau of Indian Standards (BIS), India’s national standards body functioning under the Ministry of Consumer Affairs, Food and Public Distribution, plays a crucial role in maintaining quality and safety across various industries. BIS administers numerous schemes, including Product Certification (ISI mark), Management Systems Certification, Hall Marking of

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Government to Launch New Scheme for Boosting Domestic Medical Device Industry

New Scheme for Domestic Medical Device Industry A new scheme aimed at strengthening the domestic medical device industry will be rolled out within the next month, Department of Pharmaceuticals Secretary Arunish Chawla announced on Wednesday. The scheme, formulated after extensive consultations with the medical device industry, was discussed during an event here. “This scheme will

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Right time to Submit USFDA 510(k): Timing Your FDA Application Strategically

Understanding the USFDA 510(k) Submission: A Critical Step for Medical Device Approval The USFDA 510(k) submission is a crucial regulatory requirement for medical device manufacturers seeking to enter the U.S. market. This process ensures that your device is safe, effective, and substantially equivalent to an existing legally marketed device. Properly timed and accurately filed submissions

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Innovative Technologies in Medical Device Manufacturing: Shaping the Future of Healthcare

An Overview of Innovative Technologies in Medical Device Manufacturing Technology plays an integral role in nearly every aspect of modern life, from personal interactions to professional settings, both formal and informal. Its influence extends significantly into healthcare, transforming how medical services are delivered, accessed, and financed. From the advent of the stethoscope and X-rays to

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How to Manage the Design and Development of Medical Devices According to ISO 13485:2016

An Overview: The design and development of medical devices is a complex and critical process, distinct from other industries due to its regulatory demands and the importance of patient safety. Managing this process effectively is essential, as any failure to meet regulatory design requirements can prevent a device from entering the market. Inadequate design can

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The Necessity of ISO 13485 Certification for Class A and B Medical Devices

The Necessity of ISO 13485 Certification for Class A and B Medical Devices- Overview ISO 13485 sets the standard for quality management systems in the medical device industry. For Class A and B medical device manufacturers in India, it supports compliance with CDSCO requirements like Form MD-7, even if not always mandatory. It provides a

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US FDA 510(k) Approval for Balloon Catheters

Balloon catheters are versatile medical devices used in therapeutic interventions across various anatomical regions, including cardiovascular, urological, gastrointestinal, and obstetric fields. These devices consist of several critical components: Catheter Shaft: A flexible tube, typically made from nylon, polyethylene, or polyurethane, which ensures ease of insertion and durability. Balloon: Located at the distal end, this inflatable

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Understanding CDSCO MD 7 and MD 9: Process and Regulatory Compliance

Understanding CDSCO MD 7 and MD 9 The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India, ensuring they meet safety and performance standards. Within its framework, MD 7 and MD 9 are critical classifications that define how medical devices are categorized and approved for the Indian market. Understanding and complying with CDSCO

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India’s First Center of Excellence in Medical Devices to be Established at IIT BHU Varanasi

India’s First Center of Excellence in Medical Devices Varanasi: The Indian Institute of Technology (BHU) Varanasi is set to establish the country’s first Center of Excellence (CoE) in Medical Devices, bringing together the production of medical devices and equipment under one roof. This pioneering initiative will primarily focus on E-mobility and biomedical devices. IIT BHU

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