Medical Device Registration process in India before manufacturers of certain medical devices can sell within India they need to be in compliance with India’s medical device regulations. Indian authorities overhauled the medical device regulatory process in 2017 with the publication of the Medical Device Rules. Previously, the medical devices manufacturers were free to sell their […]
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India’s CDSCO Issues New List of Medical Devices Under Medical Device Rules 2017 India’s CDSCO Issues New List of Medical Devices and provided clarity on classification of these devices, but the regulator appears to have broken down larger groups of devices such as “cannula” and “stents” into more specific sub-groups such as “ureteral stents” and
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Medical device design consulting Medical device design refers to the process of creating and developing medical devices that are safe, effective, and user-friendly. It involves a multidisciplinary approach that integrates engineering, design, human factors, and regulatory compliance to produce devices that meet the specific needs of healthcare providers and patients. In the fast-evolving field of
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Why Oxygen Equipment Manufacturing Matters Oxygen equipment manufacturing is essential in healthcare, research, and industrial sectors. Oxygen is a fundamental element for life, used not only in medical treatments but also in scientific experiments and industrial applications. With increasing demand, efficient and compliant oxygen equipment manufacturing is more critical than ever. At Operon Strategist, we
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How Do Medical Ventilators Work? Medical ventilators play a crucial role in supporting patients who struggle to breathe on their own. These life-saving devices operate by applying positive pressure to push air into the patient’s lungs, alleviating strain on the body and promoting recovery. The fundamental mechanism involves delivering a controlled mixture of air, oxygen,
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Medical Device Classification in Europe: An Overview Successfully bringing a medical device to the European Union (EU) market begins with classifying it correctly. While the EU’s classification system shares some similarities with the FDA’s, it has distinct differences. Understanding this system, governed by the EU Medical Device Regulation (EU MDR 2017/745), is essential. It involves
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Introduction: Why Surgical Bandage Manufacturing Matters Surgical bandages are one of the most widely used medical devices in hospitals, nursing homes, and healthcare centers. They are essential in wound care, post-surgical recovery, and emergency treatment. With the growing healthcare sector in India and globally, setting up a surgical bandage manufacturing plant presents a profitable and
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FDA Medical Device Classification states that a CLASS I MEDICAL DEVICE, as well as Class II and III, are “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part or accessory” that’s recognized as a pharmaceutical or supplement, intended as a diagnoses, cure, or preventive treatment
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FDA Design And Development Planning is to ensure that good quality assurance practices are used for the design of medical devices and that they are consistent with quality system requirements worldwide, the Food and Drug Administration revised the Current Good Manufacturing Practice (CGMP) requirements by incorporating them into the Quality System Regulation, 21 CFR Part 820.
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Certificate to foreign government FDA is required by many medical device market regulators in Asia, the Middle East, and Latin America in order to legally sell your product in their territories. A CFG confirms that your device has been cleared or approved for sale in the US. You can present your CFG to regulators in
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