Medical Device Design & Engineering Since 1999
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 […]
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 […]
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, […]
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 […]
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 […]
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 […]
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 […]
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 […]
What Are the First Steps to Take a Medical Device Prototype to Get Regulatory Clearance? One of the most exciting moments for medical device developers is when their idea is brought to life through a prototype. After the first initial prototype, engineers will keep iterating the design and developing new prototypes. Because of the iterations […]
This week we are discussing what FDA classifies Class I Medical Devices as. Stay tuned for Class II and Class III in the coming weeks! The FDA plays an essential role in protecting public health by regulating health products. To regulate medical devices, the FDA has a number of different requirements. However, not all medical […]
