Discover how regulatory consultants help medical device manufacturers thrive in Canada’s complex compliance landscape: real-life insights.
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Introduction In the world of medical devices, ensuring patient safety and efficacy is paramount. The 510(k) submission process is a
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Navigating the complex medical device regulatory process can often feel like decoding a cryptic language. Manufacturers grapple with an intricate
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Are you a medical professional or someone involved in the healthcare industry? If so, you’ve likely come across the
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The U.S. Food and Drug Administration (FDA) published two final guidelines on March 24, 2023, to help manufacturers of medical devices transition
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Medical devices play a crucial role in modern healthcare, providing patients with life-changing treatments and improving the quality of
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As a business owner in the medical industry, you understand the importance of providing quality products and services to your
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As a medical device manufacturer, getting your product to market can be a complex process with various regulatory requirements to
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As technology continues to advance, the use of Software as Medical Devices (SaMD) is becoming more prevalent in the
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Introduction: Manufacturing and selling medical devices in Canada can be a complex process and requires adherence to Health Canada’s
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The price for an MDEL (Medical Device Establishment Licence) and MDL (Medical Device Licence) in Canada varies according to the
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What are Class 1 Medical Devices? Class 1 medical devices are the lowest risk category of medical devices, as they
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Submitting a 510K Premarket Notification is an essential step in the process of getting medical devices approved by the
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The Medical Device License is a legal document required to manufacture, sell, and distribute medical devices. The Medical Device Licence
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The FDA or U.S. Food and Drug Administration recently announced the Fiscal Year Medical Device User Fee (MDUFA) amendments. The
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The Medical Device License is a legal document that is required for the manufacture, sale, and distribution of medical
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Who Needs an MDSAP Certificate? Anyone looking to manufacture a Class II, III or IV medical device in Canada requires
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