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Articles written by Sandra Maddock, RN, BSN, CCRA

Building a Basic Good Clinical Practice Foundation to Weather the Storm

by Sandra Maddock, RN, BSN, CCRA | Aug 2012

OMTEC 2012 opening panel presenters, consisting of David Floyd, Bill Plovanic, Bill Kolter and Brian Moore, painted a compelling picture of the current status and upcoming challenges facing the orthopaedic industry.  According to the panel, orthopaedic sales, which saw a decline in 2010, now ap ... Read more »

Daily Documentation Essentials: A Tour of the Regulatory Binder

by Sandra Maddock, RN, BSN, CCRA | Jun 2012

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 »

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

by Sandra Maddock, RN, BSN, CCRA | Mar 2012

In an effort to promote innovation while protecting the population at large, the US Food and Drug Administration (FDA) has for several years been on a course to revise the existing regulatory pathway surrounding the 510(k) process for medical devices. One topic of concern focuses upon clinical data. ... Read more »