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Articles Tagged "postmarket"

Computational Modeling and Simulation Expanding in Orthopaedic Device Life Cycles

Computational modeling and simulation (CM&S) can revolutionize medical devices by accelerating innovation and providing evidence of long-term safety.... Read more »

A Watchful Eye on Device Performance can Decrease Postmarket Surveillance Burdens

by BONEZONE | Jan 2017

Our global industry requires companies to develop harmonized postmarket surveillance systems that minimize inconsistencies in our understanding of product lifecycle risks.... Read more »

One Answer to Your Postmarket Challenge: Planning

by Vicki Anastasi | Dec 2016

Planning goes a long way in moving from premarket to postmarket data collection. Vicki Anastasi, an OMTEC 2016 speaker, suggests the best way to start.... Read more »

UDI Ruled a Requirement for EHRs

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 »

CDRH Proposes Nationwide Postmarket Surveillance System

by BONEZONE | Apr 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 »

CDRH 2014-2015 Priorities Focus on Clinical Trials and PMAs

by BONEZONE | Feb 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 »

Postmarket Surveillance and Vigilance: Making Risk-based Decisions

by John Gagliardi | Dec 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 Post-Market Imperative: Understanding the requirements for effective post-market clinical follow-up

by Hamish Forster, Ph.D. | Aug 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 »

Notified Body Requirements for Clinical Literature Evaluation

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 »