Medical Device Design & Engineering Since 1999
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 […]
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 […]
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 […]
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 […]
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 […]
What Type of Medical Device Holds a III Classification? 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 […]
