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. 
 

Design 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
 

Verify Characterize

Mikron’s process characterization ensures your product is ready for manufacturing.

This helps you identify criticical processes at an early stage and optimize your manufacturing step by step.

We help you understand the characteristics of your manufacturing processes
 

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

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

Lithuania, Kaunas

UAB Mikron Kaunas

Darius Belazaras

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

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
service.msh@mikron.com

Office hours:
08.30 – 18.00 UTC

Function
Customer Service
Countries
China

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
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