Learn the Benefits of QMS Medical device companies often have difficulty developing a quality management system. The medical device sector is heavily regulated, therefore having the proper system is crucial to ensuring that we deliver the right product to the clients. Many companies and many device manufacturers believe that developing a QMS is a simple […]
An Overview: 3D printing is a rapidly growing technology in a variety of fields, particularly in dental laboratories, as a result of these types of new technologies the speed of production and quality of product increases, which is beneficial for doctors as well as for patients to make their experience more pleasant through reducing the
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Introduction: Companies that manufacture medical devices and sell products in the UK must now make strategies for how they will get a UK Conformity Assessment. The CE mark, which has been required by EU law since 1985 for medical devices supplied in the UK, may continue to be visible. The UKCA mark will be in
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Growing Market Demand for The Orthopedic MedTech Industry During the pandemic, the market for orthopedic equipment had a significant drop in sales. The market has, nevertheless, steadily improved and internationally surpassed the pre-Covid level. The market for orthopedic devices is expected to expand in 2023, and there has been a significant increase in demand for
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In accordance with GSR 102(E), dated February 11, 2020, the Medical Device Rule 2017 will now be in effect beginning October 1, 2023, and non-notified medical devices of classes C and D that are currently required to be registered will be subject to a licensing system. It is pertinent to mention that, as per Medical
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Overview Identifying the best predicate device for FDA approval can be a critical first step in the development cycle for startups and smaller medical device companies. If the manufacturer is unable to demonstrate that the device is substantially equivalent to predicate devices. Manufacturers are required to submit premarket notification through a 510(k) submission to the
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The FDA’s Center for Devices and Radiological Health (CDRH) has released a draft guidance on predetermined change control plans for Artificial Intelligence (AI)/Machine Learning (ML)- enabled medical devices. The guidance proposes a science-based approach to ensure that such devices can be safely and effectively modified, updated, and improved in response to new data. The approach
What new changes have been made to the EU MDR Transition Period? The changes include, subject to certain conditions, an extension of the transitional period for higher-risk devices, such as pacemakers, to comply with EU MDR requirements until December 31, 2027. Subject to certain conditions, the transitional period for medium and lower-risk devices, such as
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What is Internet of Medical Things ?(IoMT) IoMT Stands for Internet of Medical Things. It is a network of medical devices that are connected to the internet and communicate with each other, healthcare providers, and patients. This allows for better diagnosis and treatment, as well as more efficient care. How is IoMT Being Used in
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Introduction: Medical Robots in Healthcare Medical robots are revolutionizing healthcare by introducing unmatched precision, consistency, and automation. Once limited to industries like manufacturing and defense, robotics now plays a critical role in medicine — especially in surgical procedures, diagnostics, and patient care. Robot-assisted surgeries are now commonplace, minimizing human error, enhancing accuracy, reducing trauma, and
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