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Legal, Clinical & Regulatory

How the European Union's MDR Will Impact Your Company's Supply Chain

OEMs must engage partners in conversations about the information needed from each party for Medical Device Regulation in order to meet regulatory requirements, timelines for CE Mark approval and make critical considerations for audits.

FDA Responds to Additive Questions on 510(k) Submissions, Reusing Powder, Testing

An agency representative, and experts from ASTM, DePuy Synthes, and SME, talked additive regulatory issues at OMTEC 2018. Among the insight provided: "Have a good process flow map of all of the steps involved. People tend to focus on the printing portion, but there are a number of steps upstream and downstream.“

12 Growing Orthopaedic Companies Expand Their Patent Portfolios

A review of patent activity in 1H18 shows technological innovations from companies like Episurf, iOrthopedics, Orthocell and Spineology across arthroscopy/soft tissue repair, joint reconstruction, orthobiologics, spine and trauma.