Posted on June 26, 2021 by DeviceLab
The FDA and other global regulatory agencies require all medical devices to be manufactured using a design control process. A design control process ensures that the medical device is developed and documented under a controlled process. The design control process is a regulatory requirement that benefits the manufacturer when employed correctly by ensuring all functional […]
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Posted on June 7, 2021 by DeviceLab
Smartwatches have been a breakthrough device and taught the medical device industry about how to gain patient adherence. Historically, wearable medical devices have not been fashionable or comfortable for patients to wear in public or use in public spaces. Smartwatches changed the wearable medical device space because these products are not explicitly medical devices; they […]
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Posted on May 23, 2021 by DeviceLab
What Are Standards? All traditional medical devices are tested against standards. Standards are documents issued by an issuing agency that is typically a non-government entity. A standard will define a broad test methodology and acceptance criteria. Government regulators will adopt standards instead of developing their own country-specific requirements, which allows for global regulatory harmonization. By […]
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Posted on April 16, 2021 by DeviceLab
According to the World Health Organization (WHO), cardiovascular disease is the leading cause of death worldwide. Healthcare providers, medical device engineers, and innovators are always looking for ways to improve outcomes for cardiovascular disease patients. One of the reasons the cardiovascular disease is so difficult to manage is because providers struggle to diagnose and monitor […]
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Posted on April 2, 2021 by DeviceLab
Wearable medical devices have been among the latest advancements in health technologies, primarily marketed by some of the most prominent Silicon Valley tech companies. While Apple watches and Fitbits might come to mind when we think about wearable medical devices, the reality is that there are many types. A wearable medical device is any non-invasive […]
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Posted on March 19, 2021 by DeviceLab
The FDA’s 4 Steps for Guiding Medical Device Design & Marketing Medical device manufacturers can market their devices in the US once they meet all applicable FDA regulations. These regulations can be broken down into four main steps and can guide medical device design. These steps simplify how the FDA regulates medical devices as per […]
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Posted on March 5, 2021 by DeviceLab
Previously, we wrote about COVID-19 making telemedicine a new normal and that it has a strong potential to remain in high usage beyond the pandemic. Telemedicine was once a niche model of health care delivery but has become more mainstream as an answer to providing healthcare during the COVID-19 crisis. Even with re-opening and the […]
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Posted on February 26, 2021 by DeviceLab
Medical device manufacturers can legally market their devices in the US once they meet all applicable FDA regulations. These regulations can be broken down into four main steps and can guide medical device design. These steps simplify how the FDA regulates medical devices as per the Federal Food, Drug, and Cosmetics Act. Step 1: Device […]
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Posted on February 12, 2021 by DeviceLab
As part of the “21st Century Cures Act” in 2017, the FDA introduced a new program for innovative medical devices and combination products designed to treat or diagnose life-threatening or irreversibly debilitating diseases or conditions. This program is called the “Breakthrough Device Program,” and it is a voluntary program to facilitate market access by […]
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Posted on January 29, 2021 by DeviceLab
Software as a Medical Device (SaMD) is defined by the FDA as “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.” Within the medical device industry, SaMD and cybersecurity have been a topic of conversation as the FDA implements a regulatory […]
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