Introduction to MDSAP vs. ISO 13485 In the highly regulated world of medical device manufacturing, ensuring the highest standards of quality and compliance is non-negotiable. Two key programs that play a vital role in this industry are the ISO 13485 and the Medical Device Single Audit Program (MDSAP). While they both aim to ensure that […]
MDSAP vs. ISO 13485: What’s the Difference? Read More »
Transforming Digital Dentistry with Precision Dental scanners have revolutionized modern dentistry by providing highly accurate digital impressions of teeth, gums, and oral structures. Using advanced imaging technology, these scanners capture detailed 3D models that enhance precision in orthodontics, restorations, and treatment planning. As digital dentistry continues to evolve, dental scanners are redefining accuracy, efficiency, and
Dental Scanners Manufacturing: The Future of Dentistry & How They’re Made Read More »
Why Is Cybersecurity of Medical Devices and IVDs Important? Cybersecurity is a critical aspect of medical devices, in vitro diagnostic devices (IVDs), and their accessories, driven by regulatory, ethical, and financial considerations. Ensuring cybersecurity is paramount for several reasons: Regulatory Compliance: To access major markets like the USA, EU, China, Australia, and the UK, compliance
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Testing and Evaluation of Medical Devices and IVDs To ensure the quality, safety, and performance of Medical Devices (MDs) and In Vitro Diagnostics (IVDs), the Ministry of Health and Family Welfare, Government of India, has registered laboratories to conduct tests and evaluations on behalf of manufacturers. This registration is under Chapter X of the Medical
Testing and Evaluation of Medical Devices and IVDs – CDSCO Circular Read More »
Big News for Medical Device Manufacturers! The Medicines and Health Regulatory Authority (MHRA) announced on May 21, 2024, that it will start accepting medical devices that already meet regulations in the EU, US, Australia, and Canada. This move aims to streamline the process for manufacturers entering the UK market, saving time and effort. However, this
MHRA to Recognize Medical Devices from EU, US, Canada, and Australia Read More »
Plastic Molding in Disposable Medical Devices Disposable medical devices are an integral part of modern healthcare, crucial in maintaining hygiene, ensuring patient safety, and preventing cross-contamination. These devices, which include syringes, catheters, test tubes, and inhalers, owe their existence to advanced plastic molding techniques. Let’s explore the importance of plastic molding in manufacturing disposable medical
The Vital Role of Plastic Molding in Disposable Medical Devices Read More »
Introduction: Navigating the complex landscape of regulatory requirements is paramount for medical device manufacturers to ensure the safety and efficacy of their products. One crucial set of regulations is outlined in 21 CFR Part 820, also known as the Quality System Regulation (QSR), established by the U.S. Food and Drug Administration (FDA). In this comprehensive
Navigating 21 CFR Part 820: Compliance and Requirements for Medical Device Manufacturers Read More »
CDSCO’s Crucial Reminder to Medical Device Companies The Central Drugs Standard Control Organisation (CDSCO) has issued a critical reminder to all stakeholders in the medical devices sector: ensure timely payment of retention fees to maintain licenses and registration certificates under the Medical Devices Rules (MDR), 2017. Failure to comply could result in the suspension or
CDSCO Urges Medical Device Firms to Pay Retention Fees to Avoid License Cancellations Read More »
Disposable Plastic Syringe Registration – Overview Disposable plastic syringes have revolutionized medical practices worldwide by offering a sterile, single-use solution for administering medications and vaccines. These syringes are crucial in preventing cross-contamination and ensuring patient safety. This blog delves into the meticulous manufacturing process of disposable plastic syringes, highlighting the steps involved, the materials used,
CDSCO Regulatory Update The Ministry of Health and Family Welfare (MoHFW) has issued a notification, S.O. 648 (E) dated 11.02.2020, listing all medical devices falling under sub-clause (iv) of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940, effective from 01.04.2020. To regulate these medical devices, MoHFW has released G.S.R. 102 (E)
