Pre-Production

Pre-Production Services

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. 
 

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 18 88  
Fax +41 32 843 18 08    
Office hours:   
08.00 – 17.00 CET 

 Contact

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

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

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  

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   
Office hours:  
08.30 – 18.00 UTC 

 Contact  

Function
Customer Service
Countries
Asia, India, Oceania, Japan

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  

Function
Customer Service
Countries
China