Evergreen Medical Technologies, a leading developer of Class III active implantable medical devices and systems, announced the addition of nearly 4,000 sq. feet of advanced technology cleanroom space to its current cleanroom facilities for the development and manufacturing of next-generation implantable medical devices. Evergreen maintains a total of more than 5,000 sq. feet of ultra-clean, med-device manufacturing space.
The company added 1,300 sq. feet of ISO Class 8 microbial-controlled cleanroom space for critical manufacturing of acute use medical devices requiring particulate and microbial control. This new facility will be used for production operations of medical devices including EP catheters, angioplasty catheters, renal denervation catheters, guidewires and other acute medical devices.
Evergreen also added a new 2,600 sq. foot, ISO Class 7 cleanroom for microelectronics assembly and production of implantable medical devices. These include pacemakers, defibrillators, neurostimulator leads, implantable pulse generators, LVAD controllers and pumps, implant tools and other chronic medical devices.
Evergreen maintains an ISO 13485 certification the internationally accepted standard for medical device development, manufacturing, and testing.
“The installation of these expanded cleanroom facilities is a major milestone in our goal to be a premier manufacturer of implantable medical devices that meet a wide range of clinical needs,” said Randy Nelson, CEO of Evergreen Medical Technologies. “The combination of our deep understanding of clinical conditions, combined with our engineering expertise and state-of-the-art facilities, gives us a full spectrum of product development resources for medical device clients.”
“This is particularly important for the latest generation of medical microelectronic technologies designed for permanent implantation in the human body,” said Nelson. “For these most sophisticated devices, post-manufacturing sterilization is not enough. They must be manufactured in a microbial-controlled environment, such as our new Class 7 clean room facility, to minimize the bioburden of pyrogenic substances that may remain and pose risks to the patient after a device is implanted.”
“Our expanded facilities allow us to offer device developers a complete production solution for active implantable devices, from microelectronic component assembly to finished implantable device manufacturing,” said Nelson. “Having high-quality production facility in one location saves time, improves efficiency, and results in implantable devices of the highest quality and safety for our clients.”
Evergreen Medical Technologies
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