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Articles Tagged "guidelines"

FDA Issues Direct Final Rule to Alter Outdated Requirements on Biologics Inspections

by BONEZONE | Feb 2018

The rule amends that inspections will be risk-based, not biennial.... Read more »

Big Changes in ISO 13485:2015?

by Robert Packard | May 2015

On February 5, 2015, a second draft of ISO 13485 was released to the world for comment. How will new quality system requirements in the latest version of ISO 13485 affect you?... Read more »

How to Avoid Risky CAPA Decisions

by John Gagliardi | Mar 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 »

FDA Recognizes Computer Simulated Performance Data in Device Evaluation

by BONEZONE | Apr 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 »

Trademarks vs. Domain Names, Part II: There is a BIG Difference

by John W. Boger, Esq. | 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 »

The Dangers of Direct Labor-Based Costing at Orthopaedic Device Manufacturers

by Douglas T. Hicks, CPA | 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 »

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 »