Cutting edge services for accelerated market launch
We offer a full suite of services, developed to help medical device manufacturers de-risk their programs and accelerate through the manufacturing design phase.
Pre-Production Services
Advise
We support your team to develop a robust design that is easy to assemble.
An important step in preparing for assembly is to check the feasibility of your product design. We work with your engineering team to develop customized analysis concepts.
We help you design a product that is ready for successful design transfer.
Characterize
Mikron’s process characterization ensures your product is ready for manufacturing.
Together with your team, we develop and execute plans to define the limits of the design and manufacturing processes.
Our process characterization is supported by proof of principle, process range studies, process capability studies, and test method development.
We help you identify critical processes at an early stage and optimize your manufacturing processes step by step.
Assemble
We offer clean room capabilities to assemble medical devices for your design validation activities.
ISO 13485 certification and qualified 2,000 sq ft Class 7 clean room facility in Denver allows Mikron customers to complete design verification builds and clinical trial builds required for regulatory approvals.
We reduce the efforts needed for regulatory submission..
Validate
We perform the medical qualification and deliver all documents for your validation.
We offer extensive validation support including, but not limited to, Standard Operating Procedures development, DOEs (Design of Experiments), process development, installation qualification, operational qualification, performance qualification and process validation.
We provide you with the qualification package based on GMP, GAMP5 guidelines required by FDA regulatory authorities.
We help generate your equipment's validation package.
Customer service contacts
Customer Service
USA, Denver
Mikron Corporation Denver
8100 S Potomac St.
Englewood, CO 80112
USA
Phone +1 303 364 5222
Fax +1 303 364 5224
Office hours:
08.00 – 17.00 MST
Contact
North America, Central America and Caribbean
Customer Service
Switzerland, Boudry
Mikron Switzerland AG, Boudry Division Automation
Route du Vignoble 17
2017 Boudry
Switzerland
Phone +41 32 843 18 88
Fax +41 32 843 18 08
Office hours:
08.00 – 17.00 CET
Contact
Europe, Middle East, Africa and South America
Customer Service
Singapore, Singapore
Mikron Singapore Pte Ltd
61 Tai Seng Ave, #05-11
Singapore 534167
Phone +65 6299 1589
Fax +65 6299 2154
Office hours:
08.30 – 18.00 UTC
Contact
Asia, India, Oceania, Japan
Customer Service
China, Shanghai
Mikron Industrial Equipment (Shanghai) Co., Ltd - China
Block 3, No. 358 Dong Ye Road
Song Jiang, Shanghai, China
Postal Code 201619
Phone +86 21 6767 9681
Office hours:
08.30 – 18.00 UTC
Contact
China
Customer Service
Lithuania, Kaunas
Darius Belazaras
UAB Mikron Kaunas
Taikos pr.114L,
51157 Kaunas
Lithuania
Phone +370 37 395545
Mobile +370 658 48152
Fax +370 37 404160
Darius.Belazaras@mikron.com
Baltic States