Regulatory Outlook
Oct 01, 2006
  REGULATORY OUTLOOK   Marcarelli Within the context of a clinical trial, a sponsor's overall goal is to advance medical technology by...
Sep 01, 2006
  REGULATORY OUTLOOK   In 1994, Underwriters Laboratories (UL) published the first edition of UL 2601-1, which ultimately replaced the traditional U...
Aug 01, 2006
  REGULATORY OUTLOOK   John Spitzley The International Organization for Standardization (ISO) has published a revised standard on the...
Jun 01, 2006
Establishing a corrective and preventive action (CAPA) system is a quality system regulation (QSR) requirement for medical device firms marketing...
Jun 01, 2006
Return to story: Best Practices: Managing a CAPA System Here are 20 tips to use when teaching employees how to investigate a problem. Of course, a...
Jun 01, 2006
Return to story: Best Practices: Managing a CAPA System • Make sure the company’s SOPs cover all necessary QSR requirements. Define the...
May 01, 2006
REGULATORY OUTLOOK If you want to learn about usability, then reading a standards document may not be the easiest starting point. However, standards...
Apr 01, 2006
Regulatory Outlook Frances Akelewicz Nancy Singer On January 26, 2006, Boston Scientific, received a warning letter from FDA. The letter...
Mar 01, 2006
REGULATORY OUTLOOK Managers responsible for conducting clinical research in the medical device industry face unique challenges. In the highly...
Jan 01, 2006
Medical Device & Diagnostic Industry Magazine MDDI Article Index Originally Published MDDI January 2006...