Product Development Medical Devices The medical device sector has a remarkable impact on the healthcare industry and is expanding its role in the global economy. It is significantly evolving over the span of years. Advancement in scientific knowledge and engineering technology has accelerated the innovation in medical devices. Medical device technology is interdisciplinary and individuals […]
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The Impact Of Change On Medical Devices Medical technology and medical device companies have a great impact on the healthcare sector. To pursue change to any technology is to keep evolving the needs of the world. Unlike others, medical device company has to make changes to their device constantly. The advancement in technology or process
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The manufacturinggeriatric of medical devices in India depends on various factors such as, increase in the population, scientific advancements, the support of government for programs of healthcare, increase in life expectancy. In addition, the rise in technology, including internet speed, artificial intelligence, and machine learning, enables development in medical device manufacturing in India. However, due to
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Introduction MDCG has combined the Q&A on addressing the most pertinent questions relating to custom-made devices falling under Regulation (EU MDR). Specifically, the MDR regulatory status of adaptable medical devices and patient-matched medical devices is clarified in this Q&A. We have provided below some questions and answers from the same document. You can find the
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Launching a new medical device in the market is not an easy task. There should be so many things that should be taken care of, the main thing is the CE mark. This is why you need a medical device consultant. Here are a few tips that you should know before hiring a consultant. Medical
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CE Approval Process for Medical Devices: An Overview Acquiring a CE mark is compulsory for medical device manufacturers seeking to introduce their medical devices into European markets. The CE mark certification process is rigorous and intricate. Here is a concise overview of the steps involved in obtaining CE approval for medical devices. Securing CE approval
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GSPR Requirements for EU MDR and IVDR the EU Parliament published on 05 May 2017 sets forth new and important requirements for medical device and in vitro diagnostic manufacturers that distribute products in the EU. New General Safety And Performance Requirements for EU MDR & IVDR is for ensuring that devices placed on the EU
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What is MDR Technical Documentation for Medical Devices? Medical Device Technical Documentation for MDR refers to a set of documents that demonstrate a specific medical device’s compliance with relevant CE marking legislation. It includes information on the product’s design, manufacture, and operation, as well as the applicable safety standards and requirements. Purpose of MDR Technical
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Medical devices are one of the most vital life-saving requirements of society. But, getting a manufacturing license for medical devices is not an easy task. Medical devices are used both internally and externally, right from diagnosis to treatment of illnesses. Hence, they are an object of the utmost concern. With medical technology progressively advancing and
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Implementing a Qms for Medical Devices Startup and maintaining a (QMS) is a crucial part of regulatory compliance for most markets worldwide. For small medical device manufacturers in the pre-production phase, an initial implementation of a partial quality system is an extremely beneficial way to ensure compliance with product development regulations, such as Design Controls.
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