Category Archives: Medical Device

FDA inspections are a fact of life for a wide range of organizations.  According to the budget request for fiscal year 2011, the FDA plans to hire more than 170 new inspectors in the field operations of the Office of … Read full article

It seems that we’ve been bombarded lately with news about the 510(k) process, which for the device industry is a critical part of innovation as it allows abbreviated reviews for devices based on previous generations, known as predicate devices. What … Read full article

This is a guest blog post by one of our industry collaborators, Nancy Singer, president of Compliance-Alliance. During her career Nancy has served as a litigator for the FDA, AdvaMed’s Special Counsel for FDA compliance and enforcement matters, an industry … Read full article

Quality personnel must have top management’s backing to keep defective medical devices from reaching the market. Richard Nass, Director of Content, Medical Devices Media Group, UBM Canon In 2004, the FDA sent a warning letter to the Satalec Action Group … Read full article

Sparta Systems: Thank you for taking the time to speak with us. To start off, can you tell our readers a little bit about Medical Device Summit?

Rick Biros: Medical Device Summit is an online b2b magazine, which follows many of the principles of a print magazine, except we do it without killing trees. We post original and contributed articles, news and blog posts to our site and then push the content out to the industry via our weekly e-newsletter. That’s the e-publishing aspect of MDS. We’re also involved in events such as webinars, one of which Sparta Systems is sponsoring this fall, and we’re about to enter into traditional live conferences. Read full article