Suture and Wound Care Device EU MDR Compliance: Why PMCF and ISO 14155 Matter?
The European Union Medical Device Regulation (EU MDR) has become very important for regulatory managers, clinical operations teams, R&D professionals, and leaders in companies that make sutures and wound care products. New strict rules were put in place by the EU MDR that affect even well-known goods like surgical sutures and wound care devices. This […]
A Regulatory Requirement for Orthopedic Implants: Post-Market Clinical Follow-Up (PMCF)
Introduction: Why Orthopedic Implants Need PMCF Particularly for high-risk products like orthopedic implants, regulatory authorities all around are tightening post-market surveillance (PMS) criteria. Manufacturers under EU MDR (2017/745) and ISO 14155:2020 have to carry Post-Market Clinical Follow-Up (PMCF) to guarantee long-term safety, effectiveness, and performance. But why for orthopedic implants is PMCF non-negotiable? And how […]
The Human Side of Compliance: How Safe Medical Devices Save Lives
Introduction: More Than Just Regulations For many medical devices manufacturers, compliance with EUMDR regulations can feel like an administrative burden—a maze of paperwork, approvals, and technical requirements. But behind every regulation is something much more important: a patient’s life. The medical devices you develop are not just products; they are lifelines. A pacemaker keeps a […]
Orthopedic Implants: EU MDR vs. FDA Essentials
Introduction: Navigating Global Regulations for Orthopedic Implants For orthopedic implant manufacturers aiming to expand their market presence, securing regulatory approval in both the European Union (EU) and the United States (US) is essential. However, the distinct regulatory pathways set by the European Medical Device Regulation (EU MDR 2017/745) and the U.S. Food and Drug Administration […]
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 […]
