Quality Control
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2023.03.28
Beware of Defective Medical Device Packaging
An FDA safety communication issued Thursday serves as a reminder that medical device packaging plays a critical role in the lifecycle of the device itself.
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2022.12.06
3 Ways to Prepare for ISO 13485/Part 820 Harmonization
Once finalized, the FDA is proposing a one-year transition period from the publication of the final rule for device manufacturers to adapt……
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2022.10.18
CMS Delves into Expanding Access for Emerging Technologies
The agency said it would work in the coming months to explore policy options…….
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2022.07.14
5 Strategies for Managing Medical Product Supply Chain Uncertainty
Utilizing real-time data to deliver customers’ orders on time—while ensuring quality and maintaining margins……
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2022.07.01
Letting the Light In: How Failure Analysis is the Cornerstone of Success
Failure analysis is a vital part of the process of developing medical devices that function safely and efficiently……
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2022.06.07
Transforming Health Care:The Drive For Digital Health and Health IT
Rapid developments in healthcare technology, combined with improved data collection, pandemic pressures and increased consumer demand for tech-enabled and virtual health care, are fueling innovation and transformation in the digital health space……
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2022.03.25
5 Thoughts on Harmonization of Quality Regulation
FDA wants to align its quality system regulation with ISO 13485:2016. Global regulatory experts share their thoughts on what this harmonization could mean for regulatory bodies and the medical device industry……
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2022.03.22
Supply Chain Readiness for 2022: Re-Assessing and Rebuilding your Suppliers
Embarking on a digital transformation in a post-COVID world will be critical for medical device manufacturers……
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2022.02.17
FDA Warns of Pediatric Feeding Tube Strangulation
FDA has received reports of two toddlers who died after being strangled by the their enteral feeding tube……
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2022.02.14
Medtronic Accused of Stealing Business from Globus Medical
Medtronic denies any wrongdoing, but Globus Medical has filed a lawsuit accusing Medtronic and four sales reps (formerly Globus reps) of stealing business……
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