The EU MDR allowed a 3-year transition period for medical device manufacturers to comply. This runway ends in May 2020, where after the EU MDR comes into full effect. After this point, every part of the medical device supply chain from manufacturers to importers and distributors in the EU, will be required to comply.
Medical Product Outsourcing VS. In-House Manufacturing
Top medical device contract manufacturers have the ability to provide comprehensive services for their OEM partners. In this article we take look at how those attributes can be maximized when a strong and healthy relationship exists.
In this article we take a look at the applications and technologies that medical device manufacturers use today, to meet the demanding conditions of catheter manufacturing.
A groundbreaking Chinese government policy change in August 2019 by the National Medical Products Administration (NMPA) will now grant any CFDA registered Contract Manufacturer the opportunity to become a Product Registered Manufacturing Contractor in China. Quasar is positioned to expand its abilities to manufacture, obtain necessary cross regional licensing, and participate as a government approved fully licensed registrant.
In this article we look into why it’s important to find the right medical device contract manufacturer, as well as important factors to consider in your selection.
FMEA, a method that helps medical device manufacturers identify, break down, control and review the risks associated with product development and manufacturing.
Medical device companies can experience difficulty determining when to start setting up a Quality Management System (QMS). The time range required to fully establish a QMS is between 3 to 9 months. In this article, we take an overview look of what a QMS is and when you need to have one in place.
In the following article we cover some of the common mistakes that are made when transferring medical device manufacturing to high volume. The ability to identify these areas at an early stage together with proper management, can be critical to a medical device’s lifecycle. These common pitfalls that result in costly corrective actions can be avoided altogether.
Introduction It’s not uncommon for companies to seek a device manufacturer after having completed the prototype development phase. That’s because they mistakenly assume that the product development team has manufacturability in mind. On the contrary, however, experience shows that during development, engineers will focus on design outputs to meet the design inputs. And not enough focus goes into product manufacturability as is necessary. It is absolutely critical to involve the device manufacturer from early on in the design phase. Otherwise, companies run the risk of developing products that will have issues with manufacturability that pose serious challenges in later stages. This study [...]
This article is a brief summary in the form of a Q&A, about the key changes and most important points of the new EU medical device regulation.
Let’s find a time to meet and discuss how we can help with your product. We are exited to showcase our special abilities in contract manufacturing for medical devices with companies in all stages of the product cycle. This time, in the grand city of Paris. Booth #M55
