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Articles Tagged "regulatory approval"

Trauma and Spine Gain New Players with First 510(k)s in 1H17

by BONEZONE | Aug 2017

In 1H17, 23 orthopaedic companies from 11 countries received their first 510(k), according to our scan of FDA’s database. Nine of the 23 510(k)s were in trauma and seven in spine.... Read more »

Don't Treat Your FDA Inspection Like an ISO Audit

by BONEZONE | May 2017

Good Manufacturing Practices/QS Regulation and ISO 13485:2016 resemble each other with respect to medical device manufacturing and design quality systems. Despite the similarities, it is the interpretation and the approach of the investigator or the auditor that makes the experience very different.&... Read more »

Once an Easy Path, Europe’s Regulatory Approval Toughens

by BONEZONE | Mar 2017

Enactment of the EU's Medical Device Regulations is expected to increase challenges for orthopaedic companies seeking CE Mark Approval.... Read more »

Spine Company 510(k)s from 1H16

by Julie Vetalice | Oct 2016

Not all spine companies attend NASS! Get to know ten recipients of their first FDA 510(k) clearances to see what technologies they’re offering.... Read more »

How to Register Your Device in Australia

by Chris Mosby | Jul 2016

This article provides a high-level view of how a company can enter the Australian market and leverage their CE Marking in the process.... Read more »

Victrex PEEK Receives Approval in China

by BONEZONE | Dec 2015

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Arcam Customer Receives China's 1st Regulatory Approval for EBM Manufactured Orthopaedic Implant

by BONEZONE | Sep 2015

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Regulatory Expert Builds Web Tool to Assist Companies with 510(k)s

by Hannah Corcoran | Jul 2015

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

FDA Outlines Stance on ex-U.S. Clinical Data

by Hannah Corcoran | Jun 2015

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Strategic Orthopaedic-related 510(k) Update

by BONEZONE | May 2015

The following companies recently received strategic FDA 510(k) clearances in the orthopaedic space. An asterisk denotes those receiving their first clearance for an orthopaedic product.... Read more »

Survey Finds Most Med Device Companies Have Positive Outlook for 2015; Same Challenges Remain

by Hannah Corcoran | Feb 2015

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

How Far is “Possible” for Risk Management?

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »