For medical device manufacturers, and FDA/ISO registered facilities, the integrity of quality systems is critical. Ensuring the quality system is suitable, efficient, and effective for business needs and customers is a key focus.
Treating CAD with bioresorbable vascular scaffolds (BRS) is considered by many to be the “next revolution” in endovascular therapy. This paper presents the basics of BRS technology, its processing and manufacturing challenges, and its advantages in use with polymer technologies.
Increased GDP and greater income per capita in developing countries means patients are becoming more proactive about their health. As a result, they can afford higher quality treatment plans and devices.
Product engineers at catheter manufacturing companies will be only too aware of the problem of delamination – the separation of material layers within the catheter. The solution lay in the design of an additional material layer between the inner etched PTFE liner and the outer jacket material of the catheter. This extra layer would deliver the crucial adhesion required to prevent delamination, ideally without increasing the outer diameter of the finished catheter.
Polyimides (PIs) occupy a particular place in commercial plastics because of their ability to tolerate and function in extremely high temperatures. This white paper discusses PI properties, their structure, and how they are synthesized for use in extreme environment applications.
There are many aspects to the process of creating a wide variety of products, but they all have something in common at the beginning. You will need to understand this common element because it's the key to a successful design.
Do no harm. Medicine’s first principle is absolutely put to the test during the new product development and innovation cycle for “high-risk” medical devices such as implants. While research and product development teams want to investigate and prove out every concept and potential outcome, they need to reduce the chance of unanticipated negative effects. Computational Modeling and Simulation (CM&S) lets you create and simulate human biologic test environments and conditions to complement the validation of safety and effectiveness by nonphysical means.
This white paper compares the general safety and performance requirements defined in Annex I of the EU in vitro diagnostic medical device regulation 2017/746 (IVDR) and the Essential Requirements defined in Annex I of the EU Directive 98/79/EC for in vitro diagnostic medical devices (IVDD).