A Pricetag for Quality?

Originally Published MX January/February 2006

INFORMATION TECHNOLOGIES

When it comes to establishing their company's quality systems, medical device executives bear heavy responsibilities that start with the requirements imposed by FDA's quality system regulation (QSR) and continue through the investor expectations of a company's entire life cycle.

Such divergent responsibilities can sometimes result in a serious dilemma, as when executives must decide how much to spend to establish their company's quality systems. If they spend too little, the company runs the risk of having an underpowered system that cannot ensure compliance with the QSR and may result in significant regulatory consequences. If they overspend, the company may wind up with a complex and expensive system that is more than its current product pipeline demands.