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Articles Tagged "federal regulations"

Medical Device Single Audit Program Attracts Growing Interest from U.S. Companies

by BONEZONE | Dec 2017

While device manufacturers were slow to adopt the program in its pilot days, the initiative has gained traction since FDA named it an official program earlier in 2017.   ... Read more »

UDI Direct Marking Guidance Finalized by FDA

by BONEZONE | Nov 2017

FDA did not offer device companies new direction on methods to direct mark, as it would be difficult to account for the wide variety of existing devices, use conditions and reprocessing methods.... Read more »

Making the Most of UDI

by Chris Mosby | Aug 2016

UDI regulations have altered your business. Gaining solid ROI from your compliance efforts comes down to internal efficiency, capturing your own master data and learning how to use that data for product development, marketing and logistics.... Read more »

Big Data Tops FDA’s 2016 Priorities

by Carolyn LaWell | Nov 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 »

Entering the Market in Argentina

by BONEZONE | Feb 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 »

FDA Draft Guidance: Refuse to Accept 510(k) Policy

by BONEZONE | Oct 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 »

Building a Basic Good Clinical Practice Foundation to Weather the Storm

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 - The Fly in the Ointment - OMTEC 2012 Opening Panel Discussion

by BONEZONE | Jul 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 Anatomy of a Warning Letter, Part Two: Excerpts and Response Strategies

by John Gagliardi | Jun 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 »

Daily Documentation Essentials: A Tour of the Regulatory Binder

The road to market approval for orthopaedic devices can be long and arduous, but it is impossible without valid data. Regulations governing practices in clinical research demand the highest level of ethical and clinical standards, with patient protection as the highest priority. Historical precedent... Read more »

The Anatomy of a Warning Letter, Part One: A Primer

by John Gagliardi | Mar 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 »

510(k) Clinical Data Requirements: Current Status and Considerations for Clinical Studies

by BONEZONE | Mar 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 »

Design Controls: Design Transfer, Changes and the Design History File

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 »