BIS 23485 Consultant BIS carries out new IS standard for Medical Devices Implementing new BIS 23485 guidelines are relied upon to make Organizations more agreeable with the fundamental standards of Safety and Performance/Quality Management System prerequisites. The Bureau of Indian Standards (BIS) has distributed another standard BIS 23485 Medical Devices – Quality Management System Necessities […]
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Upcoming Medical Device Park in India India is witnessing a transformative shift in the healthcare and medical device manufacturing sector. With the government’s focused push towards self-reliance and reducing import dependency, several medical device parks are being developed across the country. These parks are designed to provide state-of-the-art infrastructure, regulatory support, and an enabling ecosystem
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Introduction Vital signs devices are essential tools in the medical field, providing critical information about a patient’s physiological state. These devices monitor key indicators such as heart rate, blood pressure, respiratory rate, and body temperature. In this blog, we will delve into the manufacturing processes of vital signs devices, explore their types, and discuss the
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Introduction of Cardiology Devices: Cardiology devices are one of the largest medical device categories in terms of sales. They rank second only to in-vitro diagnostic devices. Cardiology devices account for approximately one in every ten medical devices manufactured. They range in size from small, implantable devices to big exterior equipment and are used to diagnose
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What is EU MDR? The EU MDR, or European Medical Device Regulation, governs the manufacturing and distribution of medical devices in Europe. EU MDR Compliance is mandatory for companies selling in this market. Even if compliant with the older MDD, the MDR introduces significant changes, requiring a proactive approach. To assist medical device companies, we’ve
What Are Implantable Medical Devices? Implantable medical devices are incredible little gadgets that work quietly inside your body, helping keep things running smoothly. These devices are designed to perform specific tasks, like supporting your heart or keeping an eye on your blood pressure, all while you go about your day without even noticing them. Some
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21 CFR Part 820 ensures your device’s safety and effectiveness. The goal of regulatory affairs is to guarantee that your organization complies with all applicable laws and regulations. These laws, such as Quality System Regulation 21 CFR Part 820, are designed to ensure that products entering the market are safe and effective. These are some
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FDA Issues Guidance on Remanufacturing of Medical Devices the Food and Drug Administration (FDA or Agency) is announcing the “Remanufacturing of Medical Devices.”A remanufacturer is defined as any person who processes, conditions, renovates, repackages, restores, or does any other act to a finished device that significantly changes the finished device’s performance or safety specifications, or
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Overview of Surgical Instruments Manufacturing Surgical instruments manufacturing is a specialized field requiring precision, quality, and regulatory compliance. Most instruments are made through one-piece forging from high-quality metals like stainless steel, titanium, tantalum, platinum, and palladium. These tools assist healthcare professionals during surgeries and clinical procedures. Choosing the right material is critical: the wrong metal
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Medical device design and development FAQ’s based on how the design and development adds value to end user and simultaneously captures profitable market share is really a tough job.Is it because healthcare is a life-critical segment? Or is it because it involves complex procedures? Apparently, both. In addition, it needs to be aligned with healthcare
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