All device establishments may suffer from the occasional “solecism” or inaccuracies associated with managing a dynamic quality management system, however, when nine Form 483 observations are documented in an agency warning letter, the QA and RA folks are more than likely fast asleep at the proverbial wheel.
The Key to Successfully Selling Medical Devices in China and Japan – Good Distributors
One of the best ways for small and mid sized Western device firms to take advantage of these growing markets is to conclude agreements with reputable, trustworthy, and well connected medical device distributors located there.
Making the News for All the Wrong Reasons
With an aging population, technological innovations and more and more people needing medical devices for a sustained quality of life, the risk of long-term harm or damages increases when devices are not manufactured, imported or used properly.
The Proposal: Marrying the Right Labeling Partner
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.
Choosing the Right Solution for Issue Management and CAPA
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.
Overcoming Barriers to Improvement in Product Development
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.
Humanitarian Use Devices and Third-Party Reimbursement
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?
UDI: What You Need to Know About Timelines, Compliance and Submissions
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.