UK and European manufacturers should put a UDI implementation plan in place ASAP.
The demands of a connected device means product designers should change their approach to software development.
How the shifting supply chain landscape and regulatory requirements will impact your business.
The United States paves the way for seamless compliance.
The agency clarifies the UDI rule for labelers and accredited issuing agencies.
Are you UDI-ready? Get the facts to achieve compliance fast.
The unique device identification rule is far more than just a labeling rule.
The agency has posted new education modules about the unique device identification rule.
From increasing focus on reimbursement and economic value, to impact of UDI and the medical device user fees, three industry experts discuss current market and regulatory trends and challenges shaping the medical device industry, and offer some effective strategies for companies to follow to remain competitive.
Labeling is a top mission-critical business systems in medical devices; label documentation not only drives patient safety, but without it, there can be no product, revenue or profit. So how can better engagement, frank disclosure and shared long-term goals help medical device companies marry the right labeling partner?