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?
Once device establishments figure out the compliance piece, life in a regulated environment becomes much more enjoyable.
CAPA provides visibility into critical product quality characteristics, failures/ non-conformances, and resolutions to these issues for smarter decisions across the global, extended enterprise. With the right solution, design, manufacturing and quality improvement teams can share the same views of the information they need to directly impact Six Sigma and Lean initiatives.
Despite a clear need to get better development lifecycle management solutions in place, companies are restricted by tight budgets, validation overhead, and bureaucracy. In this Q&A, Matt Harp and Angie Pepiot at Seapine Software share their insights.
If internal audits are performed with significant rigor and are truly being employed to identify and correct organizational issues, such audits become your best friend.
Payers often apply the same evidence standards to Humanitarian Use Devices as other devices and demand high quality clinical trials, following an approach similar to the PMA or 510(k) regulatory pathways, where payers frequently impose a higher evidence standard than FDA. But how flexible are payers in setting their evidence requirements? Will they consider HUDs as investigational?
The legislated FDA Unique Device Identification regulation is a single device identification system that is invariable, absolute, standardized, and globally reconciled. All medical device manufacturers will be required to comply with the new UDI approach. Here’s some information for you to get started.
Requiring clear supplier agreements can force some tough conversations. Acme Monaco’s Lucas Karabin, and Hogan Lovells attorney Jodi Scott, discuss the importance for such agreements, and what they should ideally cover.
Here are 5 strategies that Western medical device companies need to adopt to tap into the growing Chinese market for devices and diagnostics.
FDA recently released changes and updated guidance documents to its pre-market assessment of medical devices. Susan Alpert, M.D., Ph.D., Principal, SFA Consulting LLC, provides the perspective of the industry and offers suggestions on what can be done to improve pre-market risk management.