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Regulatory

How the EU’s MDR Will Impact Your Supply Chain

The forthcoming EU Medical Device Regulation will impact your supply chain, both in manufacturing and distribution. You must talk with your partners now to ensure that you possess the information you need from them—and they from you—to meet regulatory requirements, your timeline for CE Market Approval and critical considerations for audits. Mike Wolf, Director of Solutions Delivery at Maetrics, outlines some talking points for you and your suppliers.

FDA 510(k) Highlights: Five Companies Gain First Orthopaedic Clearances

To meet your need to know who’s new in the orthopaedic market, I sorted through the 21 companies receiving their first orthopaedic-related FDA 510(k) clearance through May of this year. To keep things simple, I then chose one company from each implantable market segment for a closer look. Here’s what I found.

510(k) Q&A: How Many Ex-U.S.-Headquartered Companies Recently Received FDA Clearance?

Recent conversations surrounding international interest in the U.S. market led us to consider how many ex-U.S.-headquartered companies have achieved an orthopaedic-related 510(k) clearance in recent years.

Postmarket Surveillance and M&A

Data collection is paramount to the success of any orthopaedic device. What happens to the much-coveted postmarket data/initiative during and after a merger or acquisition? We posed this question to Vicki Anastasi, Vice President & Global Head, Medical Devices & Diagnostics Research with ICON plc.

Spine Company 510(k)s from 1H16: Newcomers Aren’t All at NASS

In 1H16, 21 companies received their first orthopaedic-related 510(k). Of these, ten were bestowed for spinal products. Of those ten companies, only four are slated to appear on the NASS floor this year.

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