From hospital equipment connected to Wi-Fi to implants that are Bluetooth-enabled, many of today’s medical devices incorporate software connected to networks. Most require connectivity to operate and some collect confidential patient and diagnostic data.
Types of Devices Include:
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Medical devices & In-Vitro Diagnostic (IVD) devices and accessories
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Software as a Medical Device (SaMD)
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Internet of Medical Things (IoMT) devices
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Medical Device Data Systems (MDDS)
Full Life Cycle Regulatory Support for Connected Medical Devices
From development through end of life, special considerations must be made for the unique risks and challenges posed by integrating software into your device. Whereas previously, we could expect the operating environment and associated risks to remain relatively static, now technology changes at warp speed which means our devices will encounter scenarios we cannot predict. Oriel STAT A MATRIX provides full regulatory lifecycle support from the design phase all the way to post-market surveillance and product updates to devices in the field. We will help ensure that you meet today’s regulatory requirements and rise to the challenges of tomorrow.
Ways We Can Assist MedTech, SaMD & IoMT Device Manufacturers
We offer a wide array of QA/RA training and consulting services specifically for medical device and IVD manufacturers. Some of our most popular classes and services among medical technology companies include: