India’s Bold Move to Deepen Trade Ties with the US In a significant move to boost global trade relations, India has proposed reducing its average tariff gap with the United States from nearly 13% to below 4%. This strategic offer is aimed at securing exemptions from current and potential tariff hikes imposed by the US, […]
India Proposes Tariff Cuts to Boost MedTech Trade with the US Read More »
As medical devices become increasingly connected through wireless, software, and cloud-based technologies, protecting them from cybersecurity threats is no longer optional — it’s a regulatory mandate. Cybersecurity compliance in medical devices involves implementing robust technical, administrative, and procedural controls to safeguard device functionality, data confidentiality, and patient safety. For medical device manufacturers, meeting cybersecurity requirements
Cybersecurity Compliance in Medical Devices: Navigating Global Regulatory Requirements Read More »
Investment Opportunities in Medical Devices: An Overview In today’s rapidly evolving healthcare landscape, investment in medical devices has emerged as a strategic avenue with tremendous potential for growth and innovation. With an aging global population, rising prevalence of chronic diseases, and rapid technological advancements, the medical device industry is attracting both seasoned investors and new
Investment Opportunities in Medical Devices Read More »
Focus on Promoting Domestic Manufacturing through PLI Scheme In a significant policy update, India will reduce import duties on medical devices covered under the production-linked incentive (PLI) scheme starting from the sixth year of implementation, as part of its Free Trade Agreement (FTA) with the United Kingdom. This phased approach aligns with the government’s vision
India to Reduce Import Duties on PLI-Covered Medtech From the Sixth Year Under FTA Read More »
Overview for Quality Challenges in the Medical Device Industry As we progress through 2025, the medical device industry continues to grapple with evolving quality challenges. At Operon Strategist, we recognize the critical importance of robust quality management systems (QMS) in ensuring patient safety, regulatory compliance, and business success. Drawing insights from recent industry reports, we’ve
Navigating Quality Challenges in the Medical Device Industry: Insights for 2025 Read More »
How Is Real-World Evidence Reshaping Medical Device Regulations Globally? Global medical device regulations are no longer relying solely on the outcomes of controlled clinical trials. Increasingly, regulatory authorities worldwide — including the US FDA, European Medicines Agency (EMA), and other regional bodies — are recognizing the value of Real-World Evidence (RWE) in informing their decision-making
Are Medical Device Manufacturers Ready for the Real-World Evidence Era? Read More »
Wearable Technology in Healthcare: An Overview We live in a time where your watch can tell you more than the time—it can monitor your heart, track your sleep, and even warn you if something’s off. That’s the magic of wearable technology in healthcare. These smart devices are no longer just fitness trends—they’re playing a real
Wearable Technology in Healthcare and All You Need to Know About Regulatory Compliance Read More »
Why 2025 Is a Smart Year to Invest? As global markets evolve and new technologies reshape industries, 2025 presents a fresh landscape of opportunities for savvy investors and entrepreneurs. The economic climate is leaning toward resilience, innovation, and sustainability—qualities that define the most promising business sectors this year. Whether you’re an investor looking for scalable
Top 5 Businesses to Invest in 2025 Read More »
Medical Device Regulatory Submissions: 10 Mistakes That Can Delay Your Approval In the competitive world of medical technology, regulatory submissions can make or break a product’s time-to-market. Despite the high stakes, companies often overlook critical details that lead to delays, rejections, or worse — market access denials. If you’re a manufacturer, quality manager, or regulatory
Top 10 Common Mistakes in Medical Device Regulatory Submissions Read More »
2025 Medical Device Trends The global medical device industry is stepping into 2025 with unprecedented momentum, driven by cutting-edge technologies, rising patient expectations, and a strong shift toward value-based, patient-centric care. From brain-computer interfaces (BCIs) to robot-assisted surgeries, clinical wearables, and remote patient monitoring, the sector is undergoing a digital transformation that’s reshaping diagnostics, treatment,
2025 Medical Device Trends: Innovations Shaping the Future of Healthcare Read More »
