More than 30 million Americans are missing some of their teeth in one or both jaws, and with a growing aging population, that’s estimated to grow substantially. According to the American Academy of Implant Dentistry, an estimated two in three Americans have one or more missing teeth, due to the increase in periodontal disease as the population ages.
Three million people have dental implants and that number is growing by 500,000 per year with an estimated market for implants to reach $1.3 billion by 2010. Dental implants are permanent fixtures of titanium posts anchored in the jawbone and topped with a replacement tooth. The technology was initially developed in Europe over 30 years ago and the success rate is remarkably high: 97 percent success rate in lower implants and 91% success rate in the upper implants.
Keystone Dental, based in Burlington, MA, was founded in March 2006, and aspires to build a market leading global brand recognized within the dental community for its integrity, trust and commitment to improving the standard of care for patients and their quality of life.
Since then, they have rapidly grown into a diversely skilled, fast-moving team of professionals committed to providing excellent customer service and producing high-quality products and services.
Keystone’s business plan called for an electronic quality management system to be implemented as soon as possible. Being an extraordinarily high volume medical device manufacturer, Keystone’s new system would have to handle an equally large volume of electronic records per year.
According to Richard Jancsy, Manager of Quality Systems, “A critical success factor for us is to effectively and efficiently manage a significant volume of regulatory documentation; in a rigorous and compliant manner…you need a reliable and highly configurable system to meet that challenge. That’s why we selected CATSWeb.”
Instead of using a manual, paper-based system that tediously captures data, the new electronic system has streamlined the process; it’s focused on capturing the essential and actionable information quickly. The implementation activity allowed Keystone to critically re-evaluate their current manual complaint handling system and design a robust solution by leveraging CATSWeb’s flexible capability.
“CATSWeb can mirror the process in a way that we get to choose, and not the other way around,” added Jancsy. Keystone will integrate the CATSWeb quality system with Salesforce.com and their IFS ERP. The first process rolling out is complaint handling and then CAPA, audits, training and change control during 2009.
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