Mikron Denver ISO 13485 certification enables broader use of its ISO Class 7 Cleanroom

Boudry, Switzerland: – Swiss-based medical assembly process specialist Mikron Automation has confirmed that its Denver facility in the USA has earned ISO13485 medical device assembly certification, broadening applications for its recently added cleanroom pre-market assembly and development area.

The ISO Class 7 controlled environment is part of Mikron’s suite of Pre -production Services.  As part of Mikron Corporation Denver’s expansion in capabilities and services for pharmaceutical and medical device manufacturers, it added a cleanroom specifically to provide medical device manufacturers with the ability to assemble not-for-sale products, such as Design Verification and Clinical Trial versions to reduce their time to market.

ISO13485 certification

Mikron Corporation Denver 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.

Development partner

Mikron Corporation Denver General Manager, Mike Gunner, commented: “This is an exciting part of our expanded offerings to our customers”.

“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,” Mr. Gunner continues.

“This latest advance confirms that we are really much more than a provider of automated assembly equipment, we are a resource for our partners – helping them launch successful products.” he concluded.

About Mikron Automation

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 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.

To date, Mikron Automation has delivered thousands of assembly solutions for a variety of drug delivery and diagnostics devices including inhalers, pens/auto-injectors, catheters, e-devices, wearables, and point-of-care tools. It also offers a constellation of high-added-value services that cover their products’ full lifecycle, wherever its customers are in the world. Mikron’s Quality Teams offer full validation support in accordance with FDA, GMP and GAMP 5 guidelines.

Further information at: https://www.mikron.com/automation-solutions/

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