Rechargeable Power Energy North America, LLC Product: Medical Device Date: 5/9/19 CMS Number: 570911 The United States Food and Drug Administration (FDA) conducted an inspection of your firm’s medical device operations, Rechargeable Power Energy North America, LLC located in Las Vegas, Nevada, from November 5 – 9, 2018. During the inspection, an FDA investigator determined...Read More

I don’t even really like to use the word retrospectiveRead More

The article “Build and Validate Safety in Medical Device Software”, available on the Medical Electronics Design Website at http://www.medicalelectronicsdesign.com or at the link provided above, provides an overview of the challenges and approaches to preventing and detecting software faults that can lead to hazardous situations. The article provides an overview of some of the relevant...Read More

This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. The pdf at the link provided contains a training template used in SoftwareCPR training on production and quality system software validation. It presents a general validation form for discussion that can be used itself for simple applications or tools...Read More

The link provided is a pdf of slides on validation of design tools presented by Carl Wyrwa of Beckman at the November 2005 ADVAMED FDA Conference. These are provided with his permission. Validation Of Design Tools Presentation Carl Wyrwa 03Nov2005 V9Read More

This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. SoftwareCPR suggestions for a validation or Part 11 master plan are that it be a high-level plan not providing detailed document or protocol formats. Generally it is best if a master plan is a transient document.  It gets constructed...Read More

Published November 1999 in “Pharmaceutical Tecnology” was the the article “Using New Techniques for Reducing System Validation Time and Cost”. This article described an approach used in an Eli Lilly drug plant for validation of PLCs and an Intellution system where many similar but slightly different programs and pieces of manufacturing equipment were used. Its...Read More