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Quality Control
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....... Read More
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...... Read More
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...... Read More
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...... Read More
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...... Read More
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...... Read More
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...... Read More
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...... 阅读更多
2022.01.28 Medtronic Recalls Atherectomy Device After Patient Injuries At least 55 patients have been injured from a catheter tip breaking off during procedures to clear blocked arteries...... Read More
At least 55 patients have been injured from a catheter tip breaking off during procedures to clear blocked arteries...... Read More
2021.10.22 7 Basic Tools That Can Improve Quality While companies have adopted different methods to control design and manufacturing outcomes, the intent is always the same: quality improvement...... Read More