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Articles Tagged "notified body"

Start Early: Converting Your Spinal Technical File into a Class III Design Dossier

by Robert Packard | Dec 2013

As part of EU Commission regulatory changes, spinal implants will be reclassified from Class IIb devices to Class III devices. OEMs with spinal implants on the market should be proactive and start planning for reclassification now.... 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 »

India Considering New Device Regulations

by John Gagliardi | Aug 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 »

Lessons Learned From Metal-on-Metal Implants

by Robert Packard | 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 »

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 »