Multi-lumen catheters are used for several different applications, including highly complicated procedures. They can also be designed with a wide range of performance characteristics. Furthermore, advances in the design of catheter devices are opening up new opportunities and making it possible to create new multi-lumen catheter products that will improve the treatment and diagnosis of … An Overview of Multi-Lumen Catheter Design
Effective catheter design and development are essential to successfully bring your idea for a new device to market. From the earliest stages of concept development through to scaled-up manufacturing, it is a complex process with a range of considerations and potential challenges that can impact success. However, with the right approach and expertise, there are … Catheter Design and Development – Key Considerations to Get Your Product to Market
If you have an idea for a new medical device and want to sell that product in the US, you will need approval from the Food and Drug Administration (FDA). Many of the products submitted to the FDA for clearance use the 510(k) regulatory approval process. What is a 510(k) submission? What types of devices … What is an FDA 510(k) Submission
Not all medical devices are the same. Some are non-sterile and pose minimal risk to patients, while others are implanted in the body and carry a high risk. Therefore, regulations for medical devices must distinguish between the different types, setting appropriate requirements for regulatory approval depending on risk. Regulators do this with a classification system. … EU Medical Device Classifications Explained
