加速市场投放的独特服务
我们提供一整套服务,旨在帮助医疗器械制造商降低其项目风险并加快制造设计阶段的速度。
我们提供一整套服务,旨在帮助医疗器械制造商降低其项目风险并加快制造设计阶段的速度。
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.
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.
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.
Switzerland, Boudry
Mikron Switzerland AG, Boudry Division Automation
Route du Vignoble 17
2017 Boudry
Switzerland
Phone +41 32 843 11 11
service.mbo@mikron.com
Office hours:
08.00 – 17.00 CET
USA, Denver
Mikron Corporation Denver
8100 S Potomac St.
Englewood, CO 80112
USA
Phone +1 303 364 5222
Fax +1 303 364 5224
service.mde@mikron.com
Office hours:
08.00 – 17.00 MST
Singapore, Singapore
Mikron Singapore Pte Ltd
61 Tai Seng Ave, #05-11
Singapore 534167
Phone +65 6299 1589
Fax +65 6299 2154
service.msi@mikron.com
Office hours:
08.30 – 18.00 UTC
China, Shanghai
Mikron Industrial Equipment (Shanghai) Co., Ltd - China
Building 4, No.2033 Husong Road
Songjiang District, Shanghai, China
Postal Code: 201601
Phone +86 21 6767 9681
service.msh@mikron.com
Office hours:
08.30 – 18.00 UTC
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