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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As a business owner operating in dietary supplements and health products, you are undoubtedly aware of the ever-evolving regulatory
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Discover the secrets behind successful Machine Learning-Enabled Medical Device (MLMD) development, risk management, and more.
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Del Health Canada is a crucial regulatory body responsible for ensuring the safety and effectiveness of drugs and medical devices
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Using a medical device import agent can offer several benefits, especially if you are navigating the complex process of
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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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In this blog, we discuss the benefits, challenges, steps, and opportunities a medical device establishment license can offer manufacturers and
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Proper documentation is essential in any business operation and is particularly crucial when it comes to PMA submissions. Preparing and
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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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https://youtu.be/yvnTszySkgg If you’re in the medical device manufacturing business, you’re likely familiar with the FDA’s regulations, including FDA Furls. However,
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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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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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Introduction: Medical devices are an important part of healthcare and play a critical role in the treatment of patients. Medical
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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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On June 28, 2021, Health Canada opened a public consultation on a Unique Device Identification (UDI) system for medical devices
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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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Health Canada has published a consultation paper on proposed changes to the regulation and oversight of clinical trials for drug,
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