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Articles Tagged "ce mark"

DePuy Synthes Announces CE Mark for BI-MENTUM Dual Mobility Hip

by BONEZONE | Mar 2020

Currently available in the U.S., BI-MENTUM is slated to enter European markets in April 2020. The system complements other hip stems with highly polished necks, including the company's CORAIL Hip System that has more than 2.5 million implantations to date.  ... Read more »

Silver Bullet Therapeutics Gains CE Mark for OrthoFuzIon Bone Screw

by BONEZONE | Jan 2020

An expanded CE Mark positions the company to improve patient care in the EU, and potentially disrupt the established commercial trauma market.   ... Read more »

AAOS Recap: Regulatory Announcements from the Hall

by BONEZONE | Mar 2019

This month’s recap highlights regulatory announcements made from the AAOS exhibit hall floor. A few products gained clearance earlier this year and the company strategically held its announcement for this month.   ... Read more »

Globus Medical Receives Clearance for Excelsius GPS

by BONEZONE | Aug 2017

Globus Medical received FDA 510(k) clearance to market their robotic guidance and navigation system, supporting minimally invasive or open orthopaedic procedures including screw placement in spine and orthopaedic surgery.... Read more »

MedTorque Gains CE Mark Approval for Torque-Limiting Products

by BONEZONE | Aug 2017

The company now holds CE Mark approval for drivers and TRI-GEAR ratchets.... Read more »

IlluminOss Presents Novel Approach to Fracture Fixation

by BONEZONE | Apr 2014

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?

A controversial interpretation of the medical device CE Marking requires risk reduction without room for economic consideration. This approach conflicts directly with the Essential Requirements of the European Medical Device Directives. In order to comply, manufacturers need to carefully review proc... Read more »

How to Choose a Notified Body

by BONEZONE | Sep 2013

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 »

Postmarket Studies in Lieu of Clinical Trials

A strategic combination of premarket and postmarket clinical studies proactively establishes a process to identify design problems and generate revenue sooner.... Read more »

The Basics: A Look at the French Medical Device Market

by BONEZONE | May 2013

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 »

Six Steps to ISO 13485 Certification

by Robert Packard | May 2013

ISO 13485 Certification is the quickest pathway to achieving CE Marking approval. Manufacturers should follow these sequential steps as a roadmap to certification.... Read more »

ECA Medical Instruments Receives CE Mark for Surgical Instruments and Kits

by BONEZONE | Mar 2013

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 Planning for Regulatory Compliance

by Robert Packard | Dec 2012

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 »

Clinical Strategy Review for CE Marking

by BONEZONE | Dec 2010

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 »

Review of Study Results: FDA Impact on U.S. Medical Technology Innovation

by BONEZONE | Dec 2010

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 »

MDD Regulations: What I Wish I Had Known

by BONEZONE | Sep 2010

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 »