Sharing more information with design partners on device function and its inherent risks can help guide better decisions during the product development process, and keep patients safer.
The program intends to promote quality in medical device design and manufacturing.
A look at some common mistakes medical device companies make when approaching risk.
The company will invest €13 million in the facility, which will make drug-coated balloons for peripheral artery disease.
Now more than ever, the time and cost involved in manufacturing components are critical factors.
In order to keep innovation and manufacturing in the United States, device companies need federal and local support.
What is Fourslide forming, what are some advantages it offers to medical device component manufacturers, and why is it ideal for certain types of manufacturing? A discussion with experts from Acme Monaco .
There are many manufacturing pitfalls associated with physical architecture, vendor selection, and details like specifying the correct coating on a part – that come with the territory. Address these five themes to avoid problems and achieve your manufacturing goals.
The evaluation and management of risk throughout the product life cycle is the single most important concept in the regulation of medical devices. Yet it is difficult to define precisely what “risk” means or how to assess it in an industry where some 115,000 devices are produced by thousands of manufacturers, employing a dizzying array of technologies destined for use in varying health settings for every imaginable indication. So who determines the risk, and where do problems typically arise?