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Legal, Clinical & Regulatory

Process Validation Requires that You First Determine Scope

What is the current industry thinking on process validation? Our Ask the Experts series posed to the question to Carolyn Guthrie, Director of Regulatory Affairs and Quality Assurance, Kapstone Medical.

FDA 510(k) Recap: 10 Shoulder Implants and Technologies

Nine shoulder replacement implants, including two stemless offerings, and one positioning guide received FDA 510(k) clearance thus far in 2019. We recap each product's specifications.   

Active Implants Gains FDA Breakthrough Device Designation for NUsurface Meniscus

Breakthrough Device Designation is designed to ensure that patients and providers have timely access to vital devices. If cleared by FDA, NUsurface would be the first artificial meniscus in the U.S. market.