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.

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.

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The Proposal: Marrying the Right Labeling Partner

By Darren Atkinson

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?

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?

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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.

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.

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Managing Pain Points in the Healthcare Supply Chain

Stringent regulations, increased product protection challenges, economic pressures and contingency management have been identified as the most significant contributors to uncertainty in the healthcare supply chain.

Stringent regulations, increased product protection challenges, economic pressures and contingency management have been identified as the most significant contributors to uncertainty in the healthcare supply chain.

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Overcoming Barriers to Improvement in Product Development

By MedTech Intelligence Staff

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.

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.

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UDI: What You Need to Know About Timelines, Compliance and Submissions

By Yasser Mohammed

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.

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.

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How to Prepare Foolproof Supplier Agreements

By Sangita Viswanathan

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.

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.

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Silicone Adhesives – Challenges and Solutions

By Sangita Viswanathan

Customers have basic goals and expectation of silicone adhesives that it can hold the device or dressing in place while the device performs the intended function, until the time the clinical objective in achieved – Kris Godbey, 3M Medical Specialties.

Customers have basic goals and expectation of silicone adhesives that it can hold the device or dressing in place while the device performs the intended function, until the time the clinical objective in achieved – Kris Godbey, 3M Medical Specialties.

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Tapping 3D Printing Opportunities in Med-Tech

By Sangita Viswanathan

Additive manufacturing capabilities align well with the needs of the medical device segment, enhancing product customization and enabling efficient, cost-effective production and delivery, describes Deloitte’s Glenn Snyder.

Additive manufacturing capabilities align well with the needs of the medical device segment, enhancing product customization and enabling efficient, cost-effective production and delivery, describes Deloitte’s Glenn Snyder.

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