Free Article Download: FDA Issues Rule to Regulate Medical Device Data Systems _________________________________________________________
On February 15, 2011, the Federal Food and Drug Administration (FDA) published a final rule that defines Medical Device Data Systems (MDDSs) and establishes the regulatory requirements applicable to MDDSs. Historically there has been confusion about the regulatory status of these products, and the new FDA rule clarifies this subset of computer products.
Read complete article.
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Software Validation And Verification Governance: A Risk-Based Approach _________________________________________________________
Software validation is a process. It is often mandated by regulatory requirements to ensure that mission-critical software applications perform according to their intended use. In highly regulated systems environments, it is well understood that software errors can have catastrophic results on regulatory controlled processes if the applications are not properly designed, tested and implemented. While much focus is given to validation testing, governance of the validation process is often overlooked.
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A Brief Update on FDA's Re-evaluation of the 510(k) Process _________________________________________________________
Change is in the air. No, we're not referring to the recent thaw in Minnesota, but rather to the looming changes in the regulations governing medical devices in the U.S.
First, a brief primer on the medical device approval process in the U.S.
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FDA Pitches 33% Budget Boost to Better Oversee Life Science Industry _________________________________________________________
The federal watchdog agency is pitching Congress and President Barack Obama for $4.3 billion for fiscal 2012, about a third more than it got in 2010. The FDA's fiscal 2011 request was for $4.03 billion, a 23 percent increase over 2010.
Dr. Margaret Hamburg, Obama's pick to lead the agency, defended that increase, calling it "crucial to the modernization" of the agency, which regulates nearly 20 percent of all products purchased and consumed in the U.S. Hamburg used similar rhetoric to back up the 2012 request.
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Poll: Are Quality System Budgets Improving This Year? _________________________________________________________
For the past 3 years, budgets have been increasingly tight across industries and country borders. However, economic indicators suggest that access to financing may be improving this year.
Is your quality system budget increasing, decreasing or staying the same in 2011?
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Survey: Design Control is Area of Quality System Requiring Most Focus in 2011 _________________________________________________________
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Monthly Newsletter
PathWise, Inc.
February 2011
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Upcoming Events
CAPA Workshops for Life Sciences
These 2-day courses, taught by former FDA Investigators, PathWise, and MasterControl industry experts, are designed to meet the requirements mandated by regulatory agencies to effectively investigate and locate causes and correct them.
March 23-24, 2011
Salt Lake City, UT
August 3-4, 2011
Boston, MA
PathWise Webinars
Integrating ISO 14971 and ICH Q9 into the Quality System
This webinar provides insight into the necessary industry standards and offers meaningful techniques that risk management professionals can use to implement ISO 14971 and ICH Q9 into their quality system.
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Integrating FDA and Trending Requirements into your CAPA System
This session offers attendees a "how-to" approach to effectively integrate the FDA's CAPA and Trending requirements, providing them with the skills necessary to develop a strong, sustainable and compliant CAPA system.
For more information or to purchase.
Conducting OOS and Non-Conformance Investigations
This webinar provides a process to effectively expedite and document OOS and non-conformance investigations to increase compliance in your organization.
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