IVDR Compliance: What Every IVD Manufacturer Needs to Know
Introduction: Understanding the New IVDR Regulation The In Vitro Diagnostic Regulation (IVDR) (EU 2017/746) has replaced the older In Vitro Diagnostic Directive (IVDD) (98/79/EC), introducing stricter regulatory requirements for in vitro diagnostic (IVD) medical devices in the European Union (EU). With the IVDR full implementation deadline set for May 26, 2025, IVD manufacturers must comply […]
Navigating the IVD Regulatory Landscape in 2025
The In Vitro Diagnostic (IVD) industry is witnessing transformative regulatory changes across global markets. As we step into 2025, medical device companies, laboratories, and manufacturers must stay ahead of compliance updates in the European Union (EU), the United States (FDA), and India (CDSCO) to ensure seamless market entry and continued operations. This article highlights the […]
Comparative Clinical Trials: How New Medical Devices Outperform Established Technologies
Introduction In the ever-evolving world of medical technology, innovation is key to improving patient outcomes and healthcare efficiency. However, proving that a new medical device is superior to an existing one requires rigorous scientific validation. This is where comparative clinical trials play a crucial role. By comparing novel medical devices with established technologies, researchers can […]
The Ultimate Startup Guide to Medical Device Regulations
Bringing a medical device to market is an exciting yet complex journey, especially for startups venturing into the highly regulated healthcare industry. Compliance with global medical device regulations is crucial for ensuring product safety, securing approvals, and achieving market success. This guide provides a roadmap for startups to navigate regulatory pathways effectively. Understanding Medical Device […]
Accelerate Your Market Success with Bioexcel -Your Trusted Partner
Breaking into the medical device and healthcare market is no small feat. With constantly changing regulations and complex compliance processes, the journey can be overwhelming. That’s where Bioexcel steps in. We’re your one-stop solution for simplifying the path to market, helping you turn innovation into success while focusing on what matters most—creating life-changing products. Why […]
India’s Medical Device Reclassification: Ushering a New Era in Regulation
In a groundbreaking move, the Central Drugs Standard Control Organisation (CDSCO) has unveiled an updated classification list for medical devices, ushering in a new era of regulatory excellence. This revision, encompassing categories like interventional radiology, radiotherapy, oncology, and Class A (non-sterile and non-measuring) medical devices, aligns with the Medical Device Rules (MDR), 2017, and international […]
Achieve Global Success with EUMDR & USFDA Compliance for Non-Sterile Implants
In the ever-evolving landscape of medical device manufacturing, compliance with regulatory standards like the European Union Medical Device Regulation (EUMDR) and the United States Food and Drug Administration (USFDA) is paramount for achieving global success. For manufacturers of non-sterile implants, meeting these rigorous requirements not only ensures market access but also reinforces trust in product […]
Boost Your Business with ISO 10993-1:2018 Compliance for Biocompatibility
At Bioexcel, we understand that in the competitive world of medical devices, achieving regulatory compliance is a key driver of success. ISO 10993-1:2018, the global standard for biocompatibility testing, is a critical milestone for any medical device manufacturer. By complying with this standard, businesses not only meet regulatory requirements but also unlock significant opportunities for […]
Maximize SaMD Innovation Profits with Effective Technology Transfer Strategies
Software as a Medical Device (SaMD) is reshaping the healthcare landscape with innovative digital solutions that improve patient outcomes, enhance diagnostic accuracy, and streamline clinical workflows. However, the journey from development to market success involves more than just innovation—it requires a seamless and strategic technology transfer process to maximize profits and unlock the full potential […]
The Role of AI in Medical Device Risk Assessment
Artificial Intelligence (AI) is revolutionizing the medical device industry, offering innovative solutions for risk assessment and management. In a highly regulated sector, accurate and efficient risk assessment is critical to ensuring patient safety, meeting compliance requirements, and accelerating product development. AI-driven tools provide unparalleled capabilities to analyze, predict, and mitigate risks throughout the lifecycle of […]
