Arrotek

All medical device design and development projects require effective project management from the start. Watch our video to find out more about our approach to project management here at Arrotek.

The treatment of coronary heart disease has advanced rapidly over recent decades. For example, in patients deemed unsuitable for cardiac surgery, the introduction of percutaneous procedures significantly reduced mortality rates. Further advances in minimally invasive approaches have improved patient outcomes even further. This includes high-risk percutaneous coronary interventions (PCI), where interventional cardiologists treat extreme cases. … Case Study: Advanced Mechanical Circulatory Support Technologies for High-Risk Coronary Interventions

In a previous blog, we gave an overview of human factors engineering and how it relates to medical device product design. It is primarily about anticipating potential user errors and making adjustments to the product’s design to reduce the risk of those errors from occurring. The primary objective is to improve safety, but human factors … Human Factors Engineering Process Overview

In product design, designing a product that works on the engineer’s bench or desk is not enough. You also have to consider real-world factors, such as who will be using the product, their level of expertise or knowledge, and the situation or environment where the product will be used. In medical device product design, it … An Introduction to Human Factors Engineering in Medical Device Design

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