Assembly solutions for Pharmaceutical and Medical devices 

When it comes to medical devices, device reliability and high quality are essential for the patient safety and can be absolutely expected from any Mikron automation equipment.

Whether it's an injection pen, auto-injector, inhaler, syringe, molecular diagnostic or other medical device, Mikron's experience with automated assembly lines provides an very high level of reliability and scalability.

Mikron offers a level of expertise unmatched in the life sciences and medtech industries. Mikron's decades of process expertise help you minimize program risk and get your medical device to market quickly.  

Our extensive experience in validation activities helps your program to move rapidly as we support your compliance requirements and regulatory documentation for FDA, GMP and GAMP 5.

We are known in the market for engineering high performance assembly solutions for large-scale production with complex processes.

But the market is no longer only asking for high-volume production:  today more flexibility is asked to assemble different devices from the same family such as pen injectors or auto-injectors in smaller batches. 

Together with your project team, we develop a customized concept for a healthcare assembly solution that fits your specifications, desired functionality and is open for future needs.

You have the option to start with a small volume, lab-scale equipment and later expand to high-volume production line, using the same processes and parameters.

If you only need to produce a few thousand samples to submit for regulatory approval, such as the EMA or FDA for testing, the lab-scale assembly platform Mikron MAIA can help. 

If your medical device is still in the testing phase, we can support your product launch with our Pre-Production services. We provide device design support, such as design for manufacturing consulting, process development studies and Proof of Principle (PoP). We also provide comprehensive validation support for small batch assembly in compliance with FDA and GAMP 5 guidelines.

As a leading provider of pharma and medtech automation solutions, we are globally present. Each Mikron Automation site provides complete support: from the sales offering to the engineering design and from the manufacturing to the installation and Customer support.

It is not without reason that Mikron is one of the most established brands within the automation industry thanks to the trust of our customers. To name just a few: Aerogen,  Aptar Group, Biocartis, Dr. Reddy’s, Eli Lilly & Company, Biocon, Flex, GSK, H&T Presspart, Nemera, Nypro, Pfizer, Sanofi, West.

Ready to bring your medical device to market? Contact us for a customized assembly solution that fits your needs.