What Are Medical Device Protocols

Blog Archive

Aug
2022

What are the Two Medical Device Prototyping Techniques?


Two primary medical device prototyping techniques have advantages and disadvantages depending on your project’s needs. This guide will help you understand both so you can make an informed decision about which fits your needs when you’re ready to move on to the next step in your project! Benefits of Prototyping Prototyping is a critical step […]

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Aug
2022

How is Wireless Technology Applied to Medical Devices?


Wireless technology has become ubiquitous in our everyday lives. From cell phones to GPS systems, it seems like there’s almost nothing you can’t do these days wirelessly. What many people don’t realize, however, is that wireless technology also offers some serious benefits to medical device development. Here are some ways wireless tech has been applied […]

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Jul
2022

Does AI need FDA approval for Medical devices?


Advances in Artificial Intelligence have made possible some incredible medical devices, but the question of whether these devices should be FDA approved has surfaced in the medical community. The answer depends on what kind of medical device you’re working with, so let’s take a look at how AI impacts different kinds of medical devices. What […]

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Jul
2022

Can Software be a Medical Device? 


We’re currently living in the most technologically-advanced era in human history. Medicine and the devices we use to stay healthy have come a long way, especially in recent decades. Some of the most significant advancements in medicine have come in the form of SaMD, or software as a medical device.  What is Software as a […]

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Jun
2022

How Do You Design and Develop Software for a Medical Device?


If you’re new to the world of medical devices, then you may not be aware of how important software development is to your product or service. An integral part of the design, development, and testing process, the software informs each step of the process and enhances many aspects of the finished product. Let’s take an […]

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Jun
2022

How Does the FDA Regulate SaMD?


The SaMD industry is relatively new, so the FDA scrambles to keep up with its health and safety regulations. However, while these policies and regulations are still evolving, the FDA does regulate SaMD. If you’re in the software or medical device industry and want to know what to expect from the FDA, you’ve come to […]

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May
2022

Are There Different Prototyping Techniques?


Rapid prototyping is a product development method that uses manufacturing technologies to quickly produce multiple iterations of a component for testing and evaluation. Rapid prototyping has been utilized by many companies and has allowed innovators to push the envelope of what’s possible in the world of technology. In fact, the method has evolved so much […]

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May
2022

What are the 4 Types of Prototyping?


Previously we have discussed the important role of prototypes in the medical device industry. Prototypes can be used to explain a new type of device, to share with company stakeholders, or to test the use of the device. Prototypes can be further defined into four main categories. There are feasibility prototypes, low-fidelity user prototypes, high-fidelity […]

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Apr
2022

What is Rapid Prototyping?


Prototyping allows for the evolution of medical device development because engineers can see and feel the physical device and make changes to get the device in a suitable space for users. However, making a prototype can be time-consuming and costly. Most medical devices are manufactured on assembly lines. It is not feasible for assembly lines […]

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Mar
2022

What are Medical Device Protocols?


Medical devices need evidence to prove they are going to be successful when they are in the hands of physicians or medical professionals. Engineers collect evidence by testing the device against all of the requirements for its safe and effective performance. Some of this testing is performed by challenging the device in a lab or […]

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