The Journey to ISO 13485 Certification: How Bioexcel Ensures Quality & Compliance for You
At Bioexcel, we specialize in guiding medical device companies through the rigorous journey of achieving ISO 13485 certification. With our expertise in quality management systems (QMS) and regulatory compliance, we ensure that your path to certification is seamless, efficient, and aligned with global standards. Whether you are a startup or an established enterprise, Bioexcel is your partner in building […]
The Power of Technology Transfer: From Innovation to Market Success
In today’s fast-paced medical device industry, technology transfer is a critical process that brings innovation to life. This journey from invention to market entry is essential for advancing healthcare and improving patient outcomes. In this blog, we’ll explore the technology transfer stages, benefits, and common challenges, along with actionable insights to ensure your medical device […]
Best Practices for Effective Post-Market Surveillance in the MedTech Sector
In the fast-evolving MedTech industry, Post-Market Surveillance (PMS) plays a crucial role in ensuring device safety, regulatory compliance, and quality improvement. A robust PMS strategy not only helps MedTech companies meet regulatory requirements but also enhances product performance and customer trust. Here’s a comprehensive guide to the best practices for PMS in the MedTech sector. […]
Real-World Evidence in Medical Device Research: Why It Matters
In today’s competitive healthcare industry, Real-World Evidence (RWE) is revolutionizing the approach to medical device research. While clinical trials have long been the gold standard for proving a device’s efficacy and safety, RWE offers a valuable complement. By leveraging real-world data, medical device manufacturers can gain deeper insights into device performance, patient outcomes, and long-term […]
Ensuring Patient Safety in Medical Device Trials
Innovative medical devices enhance patient care, but ensuring patient safety in clinical investigations is crucial for regulatory approval & successful outcomes. In this blog, we will explore the key aspects and best practices for ensuring patient safety during medical device clinical investigations. 1. Understanding Regulatory Frameworks The medical device industry is highly regulated, and strict […]
The Importance of Clinical Trials in the MedTech Industry
Clinical trials ensure safety, efficacy, and regulatory compliance for MedTech devices, driving innovation and market success in the healthcare industry. Why Clinical Trials Matter in MedTech 1. Ensuring Safety and Efficacy The primary goal of clinical trials is to confirm that a new medical device is safe and works as intended. Through a series of […]
CDSCO Manufacturing License for Medical Devices
CDSCO regulates medical devices in India. Companies must obtain a manufacturing license from CDSCO to legally manufacture devices and ensure regulatory compliance. What is the CDSCO Manufacturing License? The CDSCO Manufacturing License falls under the CLAA (Central Licensing Authority Approval) Scheme, granted by the State Licensing Authority and approved by the CLAA, provided the licensee […]
Quality Management System for Medical Devices in India
Introduction India’s medical device sector is one of the fastest-growing markets globally, with increasing demand for compliance with quality standards to ensure the safety and efficacy of products. A Quality Management System (QMS) forms the backbone of regulatory compliance, ensuring that medical devices meet the necessary standards throughout their lifecycle from design and development to […]
Test License Application for Medical Device Manufacturing
Before medical devices hit the market in India, manufacturers need a Test License for clinical testing. Bioexcel Lifesciences can guide you through the entire process seamlessly. Understanding the Test License: Forms MD-12 and MD-13 What is a Test License? A Test License is required for manufacturers who intend to produce medical devices for testing, validation, […]
CDSCO Medical Device Registration in India: A Complete Guide
The Central Drugs Standard Control Organization (CDSCO) governs the registration of medical devices in India. As the medical device industry grows, understanding the CDSCO process becomes essential. This blog provides a concise overview of the CDSCO registration process, its importance, and key steps involved. Understanding CDSCO and Its Role CDSCO, under the Ministry of Health […]