医疗器械前期生产服务

医疗器械前期生产服务

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。 
 

Advise 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 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.  
 

Validate 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

Switzerland, Boudry

Mikron Switzerland AG, Boudry Division Automation

Route du Vignoble 17 
2017 Boudry 
Switzerland

Phone +41 32 843 11 11 
Fax +41 32 843 18 08 
service.mbo@mikron.com 

Office hours:  
08.00 – 17.00 CET

Function
Customer Service
Countries
Europe, Middle East, Africa and South America

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

Function
Customer Service
Countries
North America, Central America and Caribbean

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

Function
Customer Service
Countries
Asia, India, Oceania, Japan

China, Shanghai

Mikron Industrial Equipment (Shanghai) Co., Ltd - China

Building 4, No.2033 Husong Road
Song Jiang District, Shanghai, China
Postal Code: 201601

Phone +86 21 6767 9681
service.msh@mikron.com

Office hours:
08.30 – 18.00 UTC

Function
Customer Service
Countries
China

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

Function
Customer Service
Countries
Baltic States