FDA compliance is obviously a pertinent issue for many life sciences [...] Read More
Quality assurance (QA) isn’t something implemented solely for consumer satisfaction. In most industries, including that of medical device manufacturing, your QA efforts have very real effects on your ability to legally conduct business in the United States, EU and other global locations.
In some cases, meeting quality management regulations may be more difficult using only in-house resources. Learn how [...] Read More
The Dangers of Relying Solely on General Guidelines to Perform Software Validation for FDA ComplianceFebruary 18th, 2014 by James Francum
The FDA has established, via the issuance of General Principles of Software Validation, far reaching and comprehensive validation requirements relating to all software utilized for “…design, [...] Read More
Although medical device manufacturers have to adhere to a number of pertinent regulations to access foreign markets, there are some that stand out amongst the others. ISO 13485 is one such standard, and many firms strive to attain compliance with it.
Why ISO 13485?
For many medical [...] Read More
The manufacture and sale of medical devices, be they intravenous catheters or operating tables, is a highly complex undertaking requiring a deft balancing of FDA regulatory concerns with ambitious output [...] Read More
Regulations outlined in FDA CFR 21 state that manufacturers must implement and maintain processes for corrective and preventive actions. Also known as CAPA systems, the implementations that deal with such actions take many forms, but they’re of the utmost importance for maintaining compliance not only in the United States, but the European Union as well.
What Does CAPA Do?
CAPA [...] Read More
Complying with Part 11 can be a difficult thing to do. This is in part due to the fact that FDA recalled all the guidances concerning the implement of Part 11 in September 2003. Companies have been left to their own means to interpret Part 11, since the FDA leaves the inspector’s interpretation to “his own discretion.”
Originally, the regulation was drafted and issued by the Agency at the request of the regulated industries. These industries [...] Read More