Cardiac Wearable Medical Devices

Blog Archive

Sep
2021

Recap of the Required Documentation for Medical Devices For Premarket Notification


A premarket notification or 510(k) is a collection of documentation that establishes substantial equivalence to an existing medical device. The FDA does not provide regulatory writers with a 510(k) form to complete but rather guidance documents. The content in these guidance documents helps writers put together a package in a format called a 510(k). Most […]

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Sep
2021

How to Classify Your New Medical Device for FDA Approval Summary


  Medical device manufacturers looking to distribute medical devices in the US are required to register their medical devices with the FDA. The registration process for medical devices differs based on the risk of the device. There are three classifications of medical devices: class I, class II, and class III. Based on the device’s classification, […]

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Aug
2021

FDA Application Process Overview


To market a medical device in the US, manufacturers need to get FDA approval or clearance for their device. Most medical devices require a premarket notification from the FDA or more commonly known as the 510(K) process. After a device’s design is finalized and all testing is complete, then the device is ready to be […]

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Aug
2021

Overview of the Medical Software Development Process


Medical software manufacturers likely find themselves developing and changing their software much more rapidly than their medical hardware counterparts. For software development, there is typically less prototype development and fewer manufacturing or supplier constraints. Still, there are more frequent future revisions to enhance features, maintain compatibility, or remove software bugs. More simply, traditional medical devices […]

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Jul
2021

Advanced Care & Alert Portable Telemedical Monitor (AMON)


Wearable medical devices have allowed patients the freedom to perform their normal daily tasks without feeling constricted by their illnesses. Some illnesses like diabetes and atrial fibrillation have forced patients to schedule their lives around dosing medications or performing testing. However, wearable forms of traditional equipment have allowed patients to discreetly monitor their health or […]

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Jul
2021

Design Controls for Medical Device Industry


For medical device design, the US FDA is interested in what is the final finished medical device and the process that led the manufacturer to the final design of the device, the device design process. Specifically, FDA wants manufacturers to ensure that the original user needs are met by the final finished medical device. To […]

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Jun
2021

6 Critical Tracks in Your Medical Device Development to Get Your Product to the Market


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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Jun
2021

Medical Alert Smartwatch


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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May
2021

Medical Software Development Standards for Healthcare Software Providers


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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Apr
2021

Cardiac Wearable Medical Devices


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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