CDSCO updates 1. Notice for all devices will be regulated in 2020 Date: 08.11.19 Various stakeholders of medical devices have raised a concern regarding the clarification with respect to Implantable Medical Device. In this regard, it is requested to refer to the fifth schedule (clause 3.5) of Medical Device Rules 2017, as under: Implantable Medical […]
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Post Market Clinical Follow (PMCF) up is an effective method that constantly helps to monitor the clinical evaluation results. This assessment and examination of clinical information relating to the medical device confirm the clinical security and execution of the device when utilized as by the intended manufacturer. A study was done following the CE checking
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CDSCO Classification for Medical Devices and IVDs – Overview The classification of medical devices by the Central Drugs Standard Control Organization (CDSCO) is governed by regulatory approvals and registrations issued under the Drugs Controller General of India (DCGI). In India, every medical device must comply with a regulatory framework based on the Drugs and Cosmetics
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Introduction of QMS Certification Training for Medical Devices: Many people believe that obtaining a QMS (quality management system) accreditation is essential for a medical device company to remain compliant. A QMS certification is a regulatory requirement that the FDA (Food and Drug Administration) and ISO auditors see as basic. It increases product quality and welfare
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Demand of Medical Devices The demand of medical devices in India has been permitted by 100 % FDI by means of programmed course in the clinics and in the medical devices sectors. Indian medical history has watched a climb significantly. To turn into an industry head and increase an edge over the contenders the makers
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Artificial Intelligence in Medical Device is the capacity of the computer program or a machine to think and learn. It is likewise a field of study which attempts to make the computer brilliant. They take a shot at their very own without being encoded with directions. In general terms, artificial intelligence implies a machine which
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Overview – Dental Implants Manufacturing Did you know the global dental implant market is projected to grow significantly due to increasing demand for durable and aesthetic tooth replacement solutions? Understanding the process, materials, and regulatory requirements is crucial if you’re considering setting up a dental implant manufacturing unit. In this guide, we will cover: What
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Clean room is a room built and maintained for that no dust, germs, bacteria or contaminants could enter inside. Clean rooms are generally pressurized, the pressurization is done by air pumps, or fans pumping air inside through a filter to prevent dust from getting inside. If any person opens the door or window the air
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Introduction to Blood Collection Tube Manufacturing Blood collection tube manufacturing is a critical process in the medical and diagnostic industry. Blood collection tubes, commonly called vacutainers, are sterilized glass or plastic tubes designed to collect, store, and preserve blood samples. They often contain additives that maintain the integrity of specific blood components for accurate testing.
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Orthopaedic Implants Manufacturing License Consultant Operon Strategist is a consultancy specializing in assisting orthopedic implant manufacturers obtain regulatory approvals. As an Orthopaedic Implants Manufacturing License Consultant, we provide expertise in regulatory compliance, documentation support, quality management systems, audits, and post-market compliance. Our services help companies navigate complex regulatory requirements efficiently, ensuring adherence to quality and
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