Pre-Production Services for Medical Devices

Unique 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

Customer Service
Switzerland, Boudry

Mikron Switzerland AG, Boudry Division Automation

Route du Vignoble 17 
2017 Boudry 

Phone +41 32 843 11 11 

Office hours:  
08.00 – 17.00 CET

Europe, Middle East, Africa and South America

Customer Service
Lithuania, Kaunas

Darius Belazaras

UAB Mikron Kaunas

Taikos pr.114L,
51157 Kaunas

Phone +370 37 395545
Mobile +370 658 48152
Fax +370 37 404160

Baltic States

Customer Service
USA, Denver

Mikron Corporation Denver

8100 S Potomac St.
Englewood, CO 80112

Phone +1 303 364 5222
Fax +1 303 364 5224

Office hours:
08.00 – 17.00 MST

North America, Central America and Caribbean

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

Asia, India, Oceania, Japan

Customer Service
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

Office hours:
08.30 – 18.00 UTC