Medical Devices

How To Register Medical Devices in India? Central Drug Standard Control Organization (CDSCO) has released the Medical Devices amendment rule and classification of non-notified medical device and In-vitro diagnostics (IVD’s) and according to that devices have been classified into 24 categories of medical devices and 3 Categories of In-Vitro Diagnostics. According to CDSCO, The registration is on voluntary […]

Making in India, Healing India: The Future of Domestic Medical Device Manufacturing The medical device industry in India is experiencing a period of significant growth and change. The market is expected to reach a value of $25-30 billion by 2025, driven by a number of factors, including: Growing Population and Rising Income Levels: India’s population

Beyond the Blueprint: How Biocompatibility Testing Safeguards Patients Every Step of the Way Medical devices play a crucial role in modern healthcare, but ensuring their safety and efficacy is paramount. Biocompatibility testing is an essential step in this process, evaluating the potential interaction between a medical device and the biological environment it comes into contact

Building Trust : Medical Device Testing in ISO 17025 Certified Laboratory ISO 17025 is an international standard that sets out the requirements for the competence of testing and calibration laboratories. Laboratories that comply with this standard demonstrate their ability to produce valid and reliable results. This gives confidence to regulatory bodies, manufacturers, and healthcare providers

Master the Maze: Navigating the Design Control Process for Flawless Medical Devices In the world of medical devices, where even minor flaws can have life-altering consequences, a robust design control process is the cornerstone of success. It’s the meticulous roadmap that guides a device from concept to market, ensuring every step adheres to the highest

Unmasking the Hidden Danger: Why Toxicological Testing Stands Guard for Medical Devices In the intricate world of medical devices, where innovative tools seek to heal and mend, a watchful eye must be kept on potential unseen threats. Enter toxicological testing, the silent guardian standing between promising technology and patient safety. It delves into the unseen,

Ensuring Accuracy and Efficacy: Performance Testing in Medical Device Development Medical devices play a crucial role in modern healthcare, diagnosing illnesses, monitoring vital signs, and delivering life-saving treatments. However, the stakes are incredibly high when it comes to these instruments, as any malfunction or inaccurate performance can have devastating consequences. This is where performance testing takes center

Ensuring Patient Well-being: A Deep Dive into Medical Device Safety Testing Medical devices play a crucial role in modern healthcare, diagnosing illnesses, treating conditions, and even saving lives. However, with their increasing complexity and sophistication comes the paramount responsibility of ensuring their safety for both patients and healthcare personnel.  This is where medical device safety testing steps

Unveiling the Truth: A Deep Dive into Dietary Supplement Testing Dietary supplements have become an integral part of modern life, promising to fill nutritional gaps and enhance overall well-being. But with a booming industry and countless products lining shelves, questions arise: are these supplements truly what they claim to be? How can we ensure their

The Unsung Guardians: Unveiling the World of Medical Device Testing Medical devices play a transformative role in healthcare, from simple bandages to life-saving pacemakers. But before these tools ever reach patients, they undergo rigorous testing to ensure their safety, efficacy, and performance. This intricate process, known as medical device testing, safeguards patients and paves the