Latest News from Brian Webster
I have some important news to share with you. Physio‐Control is now shipping our entire product line worldwide, without restrictions. We have received approval from the U.S. Food and Drug Administration (FDA) to resume unrestricted shipments, following our most recent Quality System inspection. We are extremely pleased to share this significant news with you.
Although this has been a challenging time in the history of our company, I am proud of the way the Physio‐Control Team has responded to these challenges. Our Team Members spent countless hours focused on improving our Quality System processes, resulting in systems that I believe are second‐to‐none in the industry. Today, our product quality is the best it has been in our history. This focus on process improvement has led to increased efficiency in our factoryproduction capacity and stability is at an all‐time high.
As an industry, we are facing an increasingly tough regulatory environment. With higher levels of scrutiny and FDA engagement, we have witnessed extensive product recalls from all of the major companies in our industry. As the market leader, we accept responsibility for raising the bar on Quality System improvement, regulatory compliance and product quality. This doesn't mean we will never experience product recalls. It means we are in a better position than ever before to detect potential issues early and respond more quickly to minimize the impact to our customers.
Our investments in Quality System improvements have also enabled us to streamline our innovation capabilities. Physio‐Control was built on providing meaningful clinical and operational improvements for our customers, so our attention to new technology development has never wavered. This commitment is evidenced by the FDA 510(k) market clearance of the LIFEPAK® 15 and LIFEPAK 20e monitor/defibrillators, the LIFENET® System 4.1 and the introduction of the LUCAS™ 2 Chest Compression System. We have also made significant investments to accelerate our innovation pipeline in the coming years.
Finally, and most importantly, we have continued to put commitment to our customers first. Our goal is simply to design, manufacture, and deliver the highest quality, most reliable, most innovative emergency medical products and services in the world. This Valentine's Day, Physio‐Control celebrated our 55th anniversary of providing lifesaving tools for lifesaving teams. Since 1955, more Physio‐Control products have been used by emergency care professionals than from any other company. I can assure you we have never been more dedicated to serving our customers and leading our industry than we are right now.
I want to thank you, our customers, for the commitment and loyalty you have shown us through the years. Our promise is to give you the same commitment and loyalty in return. As always, if you have any questions or concerns, please contact me or one of the more than one thousand Physio‐Control Team Members worldwide.
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