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.
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
In this article we outline the FDA medical device classification process.
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 in the great city of Boston. Booth #229
Israel is considered to be amongst the world leaders in the field of medical devices. The total number of granted patents in the area of medical devices, positions Israel at the first place in the world in patents per capita, and in the fourth place in terms of absolute number of patents.
ISO 13485 manufacturing is an established quality standard, pertaining to medical device manufacturers. However, as with any quality standard, it is more a set of general guidelines which every manufacturer applies to their own situation according to their status, infrastructure, and working conditions, rather than a recipe for success. There are multiple ways in which it can be applied to each manufacturer’s case, therefore making each medical device manufacturer responsible for guaranteeing their operational effectiveness and success, independent of their ISO 13485 manufacturing certification. An Overview Of ISO 13485 Manufacturing Quality Standard First published in 1996, ISO 13485 in manufacturing is [...]