Arrotek

According to the EU MDR (European Union Medical Device Regulations), medical device manufacturers must, in some circumstances, appoint a European Authorised Representative in order to obtain CE certification for their products so they can be sold in Europe. What is a European Authorised Representative, though? According to the definition in EU regulations, an Authorised Person … What is an EU Authorised Representative, When Do You Need One, and What Do they Do?

The steerable and deflectable catheter design process helps produce some of the most advanced minimally invasive medical devices currently in use. This includes both diagnostic and therapeutic catheter devices. Furthermore, technology advances mean it is now possible to design advanced catheter technologies that are more complex than ever before. Steerable and deflectable catheters are designed … An Overview of Steerable and Deflectable Catheter Design

The process for bringing your idea for a new medical device from the concept stage through to commercialisation is known as a New Product Introduction, or NPI. The exact steps required will depend on the device you plan to develop. As each marketplace has varying regulatory requirements, where you plan to launch will also influence … The New Product Introduction Regulatory Process for Novel Medical Device Innovations

Intellectual property (IP) is a high priority consideration when designing a new medical device. If you are outsourcing all or part of the development to a third-party contractor, it’s even more important to take steps to ensure your IP is protected. There are many reasons for this, but one of the most important is that … 6 Tips to Protect Your Intellectual Property When Outsourcing Medical Device Design

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