Medically necessary vs. safe and effective. Can clinical trials, by design, realistically satisfy the needs of two Federal agencies with...
Continuously hammered by Congress, news media and the international health community, the U.S. FDA has responded with a five-year plan...
FDA analysis of factory inspections has shown that manufacturers who do not have an adequate quality audit system usually do...
The product design is flawless. The clinical trial endpoints were met. FDA has given the green light to begin marketing....
The medical device industry faces a number of significant challenges. Federal health care reform, unpredictable U.S. regulatory pathways and an...
For the past several years, Congress has debated several bills that would change the way that patent laws are currently...
This article summarizes key elements required for technical documentation of medical devices provided by manufacturers in order to demonstrate conformity...
The orthopaedic industry faces strong pressure from regulatory bodies as well as from the industry to maintain the quality of...
Within the past 18 months, a cottage industry has started to emerge. This disruptive industry exists to sue companies for...
The most recent revisions to the European medical devices directive have underlined the importance of clinical data in demonstrating compliance...
The Notified Body British Standards Institution (BSI) has launched the Clinical Strategy Review for manufacturers applying for CE marking. (See...
FDA Impact on U.S. Medical Technology Innovation, a study released in November 2010, was undertaken to provide a view of...
What differentiates CER from traditional medical research is that CER is demand driven....
Copyrights are rampant in the world of orthopaedics and are, most of the time, ignored or forgotten. Copyrights can be...
Introduction and Review As you may recall from the first and second articles in this series, each manufacturer of orthopaedic medical...