Fda Classification Class Ii Medical Devices Overview

Blog Archive

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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Mar
2022

What are the Four Types of Medical Technology


In today’s medical device environment, there are four main types of medical technology: telehealth, robotic surgery, artificial intelligence, and wearable devices. These technologies have made major breakthroughs in advancing human health. Telehealth Telehealth is the use of digital information and communication technologies (ICT), such as computers and mobile devices, to access health care services remotely […]

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Feb
2022

TracPatch: a Medical Device Developed by DeviceLab Wins Best Wearable at Sensor Converge Expo 2021


Wearables are the go-to solution for people who want to closely track and manage their wellness. They can provide useful information such as tracking your temperature, blood pressure, blood oxygen, respiration rate, location, bodily movement, and so much more, including your body’s electrical activity. This includes the activity of the heart, muscles, brain, and skin, […]

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Feb
2022

How Do You Develop Medical Equipment? 


Medical devices and wearables are among the most revolutionary developments in healthcare. Both are examples of modern and innovative medical equipment that require a significant amount of time and work to achieve. The exact process of medical device development might vary from place to place and country to country. However, you’re expected to adhere to […]

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Jan
2022

Why is Medical Device Compliance so Important?


Medical device companies have to comply with many different regulations with US regulatory agencies and globally. At times this can feel burdensome and overwhelming; however, manufacturers should keep the bigger picture in mind and build regulatory compliance into their company’s culture. Ensuring regulatory compliance can provide companies with the assurance their product is safe for […]

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Jan
2022

FDA Classification Overview: Class III Medical Devices


Previously we’ve discussed FDA Class I medical devices, which are the lowest levels of risks. But what about medical devices that are the riskiest or have the most unknown risk? The FDA regulates medical devices based on the risk-benefit profile. Medical devices with a higher risk profile or lower perceived benefits are classified as Class […]

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Dec
2021

Why Design Matters in Medical Software Development


Software development can happen very quickly. Software developers can make improvements and enhancements to software easily without the need for physical products. Medical devices have not historically been products that iterate very quickly. Largely, this is because of design controls. A manufacturer must identify the needs of their medical device and the medical device must […]

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Dec
2021

FDA Classification: Class II Medical Devices Overview


The FDA regulates medical devices by their risk level and each medical device fits into one of three classes. Class I are medical devices that have the least risk to the patient and Class III are the most risky medical devices. However, roughly 50% of all US medical devices are regulated as class II medical […]

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