Mikron Corporation Denver earns ISO 13485 certification
Mikron Corporation Denver
As part of Mikron Corporation Denver’s expansion in capabilities and services for pharmaceutical and medical device manufacturers, it has added a cleanroom to its Denver, Colorado facility. This ISO Class 7 controlled environment is part of Mikron’s suite of Pre Production Services. Mikron invested in the cleanroom specifically to provide medical device manufacturers with the ability to assemble not-for-sale product, such as Design Verification and Clinical Trial product to reduce their time to market.
Mikron has earned the ISO13485 certification by demonstrating that it has practices and procedures in place for the assembly, verification, and functional testing services for Medical Devices in an ISO 7 classified cleanroom. This includes the quality system and controls required in the creation of all the necessary documentation, environmental monitoring, performing inspections, carrying out process development studies, validation execution and the release of the assembled product for use in trials.
This is an exciting part of our expanded offerings to our customers,” says General Manager, Mike Gunner. “Through our cleanroom and our Pre Production Services, we can help our partners with their need to accelerate through the product development cycle and get into commercialization faster and with less investment. We are really much more than a provider of automated assembly equipment, we are a resource for our partners - helping them launch successful products.”
Mikron Corporation Denver is part of Mikron Automation - a division of the Mikron Group. Mikron Automation is the leading partner for scalable and customized assembly systems – from the first idea to the highest performance solutions. Distinguished by a commitment to innovation, flexibility, unparalleled customer service, and an evolving platform portfolio, Mikron delivers state-of-the-industry solutions to the most complex assembly and testing demands.
Mikron Automation has produced and installed more than 3’900 assembly and testing systems worldwide to customers in the pharmaceutical, medtech, automotive, electrical/industrial and consumer goods. Mikron Automation currently employs around 750 people and is headquartered in Boudry (Switzerland), a region that is regarded as the heart of the Swiss watchmaking industry. It also has sites in Denver (USA), Singapore, Shanghai (China) and Kaunas (Lithuania). The Mikron Group, a publicly-traded company with more than 100 years’ experience in precision machinery.