Medical Device Design & Engineering Since 1999
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 […]
Great ideas in medical innovation can come from anyone, from engineers, healthcare providers, and even patients. Some of the biggest disruptors in healthcare development did not necessarily start with a large fortune 500 medical device company. Developers in any field have to go through a lot of thought experiments, but in the medical industry, they […]
During the medical device design process, engineers will spend countless hours prototyping by creating specifications, designing CAD drawings, and manufacturing physical products. These prototypes and their iterations are essential to the development of the device. Medical device development evolves with each prototype. With each prototype, the design of a medical device gets one step closer […]
A premarket notification or 510(k) is a collection of documentation that establishes substantial equivalence to an existing medical device. The FDA does not provide regulatory writers with a 510(k) form to complete but rather guidance documents. The content in these guidance documents helps writers put together a package in a format called a 510(k). Most […]
Medical device manufacturers looking to distribute medical devices in the US are required to register their medical devices with the FDA. The registration process for medical devices differs based on the risk of the device. There are three classifications of medical devices: class I, class II, and class III. Based on the device’s classification, […]
To market a medical device in the US, manufacturers need to get FDA approval or clearance for their device. Most medical devices require a premarket notification from the FDA or more commonly known as the 510(K) process. After a device’s design is finalized and all testing is complete, then the device is ready to be […]
Medical software manufacturers likely find themselves developing and changing their software much more rapidly than their medical hardware counterparts. For software development, there is typically less prototype development and fewer manufacturing or supplier constraints. Still, there are more frequent future revisions to enhance features, maintain compatibility, or remove software bugs. More simply, traditional medical devices […]
Wearable medical devices have allowed patients the freedom to perform their normal daily tasks without feeling constricted by their illnesses. Some illnesses like diabetes and atrial fibrillation have forced patients to schedule their lives around dosing medications or performing testing. However, wearable forms of traditional equipment have allowed patients to discreetly monitor their health or […]
For medical device design, the US FDA is interested in what is the final finished medical device and the process that led the manufacturer to the final design of the device, the device design process. Specifically, FDA wants manufacturers to ensure that the original user needs are met by the final finished medical device. To […]
