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 ft2 (185m2) 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.
Sales contacts
Sales Representative
USA, Denver
William Jaworski
Sales Director
Mikron Corporation Denver
8100 S Potomac St.
Englewood, CO 80112
USA
Phone +1 303 364 5222
Fax +1 720 858 2198
sales.mde@mikron.com
North America, Central America and Caribbean
Sales Representative
Switzerland, Boudry
Lorenz Buri
Sales Director
Mikron Switzerland AG, Boudry
Route du Vignoble 17
2017 Boudry
Switzerland
Phone +41 32 843 11 11
sales.mbo@mikron.com
EMEA and South America
Sales Representative
Singapore, Singapore
Stéphane Mentha
General Manager
Mikron Singapore Pte. Ltd.
61 Tai Seng Ave, #05-11
Singapore 534167
Phone +65 6299 1589
stephane.mentha@mikron.com
Asia, India, Oceania, Japan
Sales Representative
China, Shanghai
Xiaolai Zhou
Sales Director China
Mikron Industrial Equipment (Shanghai) Co., Ltd.
Building 4, No.2033 Husong Road
Song Jiang District, Shanghai, China
Postal Code: 201601
Phone +86 182 2115 5896
xiaolai.zhou@mikron.com
China