Introduction: The Rise of GLP-1 Pen Injectors In the evolving world of injectable therapies, GLP-1 pen injectors have emerged as a breakthrough innovation for the treatment of type 2 diabetes and obesity. With the rise in chronic lifestyle diseases, the demand for safe, convenient, and user-friendly drug delivery systems has soared making GLP-1 pens a […]
GLP-1 Pen Injectors: Regulatory Classification & Market Growth Read More »
Introduction When it comes to medical devices, packaging isn’t just about appearance, it’s about protecting the product, maintaining sterility, and ensuring safety until the point of use. Medical device packaging plays a vital role in ensuring the device reaches the end-user in the condition it was designed for. One critical aspect of this is shelf-life
Medical Device Packaging Shelf-Life: Validation, Testing & Compliance Read More »
SaMD Software Documentation:An Overview As Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD) continue to transform modern healthcare, regulatory bodies like the US FDA have established stringent documentation requirements for premarket submissions. If you’re planning to bring your software-based medical device to the US market, the Center for Devices and
SaMD Software Documentation: 7 Must-Haves for Premarket Submissions Read More »
Introduction India is witnessing a significant push in medical device manufacturing under the government’s Production Linked Incentive (PLI) scheme. As of March 2025, 21 approved projects have started manufacturing 54 unique medical devices, including critical equipment like MRI machines, CT scanners, dialyzers, and heart valves. The PLI scheme, designed to strengthen domestic manufacturing and reduce
PLI Scheme Boosts Medical Device Manufacturing in India with 21 Projects and 54 Devices Read More »
Overview of Medical Device Labeling and Its Regulatory Importance Medical device labeling is a critical element of regulatory compliance and user safety. For manufacturers aiming to market medical devices globally, accurate and compliant labeling is not optional—it’s a mandatory requirement enforced by regulatory authorities such as the US FDA, the EU under MDR, and various
Medical Device Labeling: A Complete Guide to Standards, Compliance, and Best Practices Read More »
Introduction: IOL Cast Molding Technology is reshaping the way intraocular lenses (IOLs) are produced by offering precision, repeatability, and efficiency. As cataract surgeries increase globally and demand grows for advanced visual correction, manufacturers are turning to cast molding to meet strict quality and regulatory expectations. Unlike traditional lathe-cutting methods, cast molding allows mass production of
IOL Cast Molding Technology: A Breakthrough in IOL Manufacturing Read More »
Introduction The medical device industry is experiencing a transformative shift in 2025, driven by innovations in 3D printing (additive manufacturing). Among its most exciting applications is the development of implantable medical devices—from orthopedic implants to cardiovascular scaffolds—customized to the patient’s anatomy and condition. With increasing regulatory clarity and materials science breakthroughs, 3D-printed implants are no
3D Printing in Implantable Devices: What’s New in 2025? Read More »
FDA Guidance on AI-Enabled Medical Devices: An Overview The FDA is reshaping how the medical device industry approaches Artificial Intelligence (AI) in 2025. With the growing adoption of AI-enabled software in medical devices, the FDA has released two critical guidance documents that will influence how MedTech companies develop, manage, and submit AI-based products. In this
FDA Guidance on AI-Enabled Medical Devices: Key Updates & Industry Impact in 2025 Read More »
In Government Pushes Fast-Track Development of ₹440 Crore Medical Device Hub in Greater Noida The central government has directed the Yamuna Expressway Industrial Development Authority (YEIDA) to complete the ₹440 crore Medical Device Park in Sector 28, Greater Noida by January 2026. Spread across 350 acres, this state-of-the-art park is set to become a national
YEIDA Medical Device Park to Be Completed by January 2026, Centre Instructs Read More »
Effective from January 10, 2025, medical device and in vitro diagnostic (IVD) manufacturers operating within the European Union must comply with new regulatory obligations to ensure the continuity of medical device supply. The introduction of Regulation (EU) 2024/1860 establishes mandatory advance notification requirements for manufacturers planning to discontinue or interrupt the supply of medical devices
New EU Rules on Medical Device Supply Disruptions Take Effect January 2025 Read More »
