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.

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……

CMS Delves into Expanding Access for Emerging Technologies

The agency said it would work in the coming months to explore policy options…….

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……

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……

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……

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……

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……

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……

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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