UK Tech and Life Sciences Firms Announce Major Expansions in India: How Operon Can Play a Key Role UK firms in the technology and life sciences sectors are making a powerful impact in global markets, with significant expansion plans now taking shape in India. As part of their global growth strategies, these businesses are forging […]
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e-QMS Implementation: An Overview Implementing an electronic Quality Management System (e-QMS) is a transformative step for medical device manufacturers seeking to enhance operational efficiency, ensure regulatory compliance, and maintain superior product quality. Whether transitioning from a manual paper-based system or upgrading an outdated e-QMS, a well-planned approach is crucial to avoid disruptions and maximize benefits.
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Nail Your Technical File Medical Device: A Compliance Guide Did you know, In the medical device industry, incomplete or poorly structured technical documentation (TD) can lead to regulatory delays, product recalls, or market rejection. Complying with MDR 2017/745 standards for TD can be challenging, but getting it right ensures faster approvals, smoother audits, and long-term
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India has commenced the domestic production of critical medical devices such as CT scanners, MRI machines, and dialysis equipment, which were previously entirely imported. This development has been confirmed by Amit Aggarwal, Secretary of the Department of Pharmaceuticals. According to Aggarwal, these medical devices are being manufactured under the Production Linked Incentive (PLI) scheme—a government
India Now Produces CT, MRI, and Dialysis Machines Under PLI Schemes Read More »
In quality management, addressing defects, nonconformities, and risks is crucial for ensuring compliance and maintaining efficiency. Organizations often implement Correction, Corrective Action, and Preventive Action (CAPA) to improve processes and prevent recurring issues. However, these terms are often confused. Understanding their distinctions, along with real-world examples and best practices, helps ensure effective implementation. Clarifying the
Understanding the De Novo and US FDA 510(k) Pathways With the rise of AI-enabled medical devices/IVDs, one question is becoming more common: “What is the difference between a De Novo and a US FDA 510(k) submission?” A common misconception is that every novel device automatically qualifies for the De Novo pathway. However, the predicate device
FDA De Novo vs. US FDA 510(k): Choosing the Right Pathway for Your Medical Devices/IVDs Read More »
India to Reduce Tariffs on Medical & Surgical Equipment During Modi’s US Visit Indian Prime Minister Narendra Modi is set to visit the United States this week, with a key agenda of strengthening healthcare trade between the two nations. As part of this initiative, India is considering tariff reductions on medical and surgical equipment, which
Ensuring Compliance in the Dental Scanners Regulation Process Bringing a dental scanner to market isn’t just about cutting-edge design—it’s about ensuring safety, effectiveness, and full compliance with the dental scanner regulation process. Without meeting strict quality and safety standards, even the most advanced scanner won’t be approved for use. What Are Dental Scanners & Why
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Medical devices play a critical role in healthcare, offering lifesaving and life-enhancing solutions to patients worldwide. While many devices are mass-produced to meet general medical needs, some conditions require personalized solutions. This is where custom-made medical devices come into play. These devices are specifically designed and manufactured for individual patients based on their unique anatomical
Custom-Made Medical Devices: Regulations, Classification, and Challenges Read More »
Overview on Union Budget 2025-26 On February 1, 2025, Finance Minister Nirmala Sitharaman unveiled the Union Budget 2025 for FY26, placing a significant focus on healthcare. The government has allocated ₹99,858 crore to the healthcare sector, marking a nearly 10% increase compared to the previous year. This allocation includes funding for key initiatives under the
Union Budget 2025: Major Boost to Healthcare Read More »
