Miltenyi Imaging stands for the design and production of Smart Imaging Solutions in the Life Science and Clinical Diagnostics market.

Miltenyi Imaging is a high-quality supplier of innovative Life Science instrumentation with proven record to reliably and flexibly design, develop and manufacture complex systems, composed of cutting-edge optics, fluidics, mechanics, electronics and software. Miltenyi Imaging is ISO 9001 and ISO 13485 certified and has established an efficient quality management system.

Our goal is to bring high-performing and reliable, yet affordable detection instrumentation to life science and diagnostic applications.

At our headquarters in Radolfzell we support our customers in more than 20 countries worldwide. Our solutions can be found in many laboratories around the world - either as standalone products or as OEM components integrated into larger systems developed by our partners.

Milestones

Since the foundation of Miltenyi Imaging, previously Sensovation, we have evolved from a supplier of specialized detection components to a developer and manufacturer of high-quality life science instrumentation with a special focus on the rapidly growing field of multiplexed analysis and digital pathology.

As an instrument supplier our focus is on quality - we strive for the highest quality standards both in engineering and manufacturing. Compliance to the well-established, though continuously changing standards is the key for our customers to reach product-approval in the relevant markets.

Miltenyi Imaging is ISO 9001 and ISO 13485 (medical products) certified, supporting customers throughout product definition, R&D and product lifetime support.

Our products conform to safety standards for our worldwide customers, including CE conformance according to EU low voltage and EMC directives, and equivalent UL/CSA in North America.

We maintain a FDA 21 CFR 820 oriented quality system to support our US customers.  

We are regularly audited and inspected by:

  • DQS Medizinprodukte GmbH (ISO-9001, ISO-13485, annually)
  • Intertek & CSA (UL/CSA conformance, quarterly)
  • Customers
  • Internal Quality Management

We manage quality and we deliver it:

  • We check all parts at incoming inspection and maintain a supplier rating system.
  • Our products are QC tested before shipment and we track any quality deviations.

We have broad experience in design and manufacturing of instruments for molecular diagnostics and pathology. A standardized development process and in-depth understanding of the applications help our customers to approach the right market, with the right product, at the right time.

We follow a structured, milestone based process. At each milestone predefined goals must be reached in the categories

  • Requirement engineering
  • Documentation
  • Quality management and product safety
  • Technical solutions and reliability
  • Test and verification
  • Certification
  • Transfer to production

Our team consists of engineering experts from all relevant disciplines, like physics, optical engineering, mechanical engineering, electronics and software engineering, backed-up by an efficient organization and experienced application specialists.

Miltenyi Imaging manufactures highly complex medical instruments for our customers and our parent company Miltenyi Biotec. The optical core components for imaging are integrated in systems including sample movement, sample preparation and liquid handling.

We have a 870 m2 (9370 sq.ft.) production area, equipped with latest manufacturing technology and a team of highly qualified staff.

  • 30 m2 (330 sq.ft.) cleanroom ISO Class 5 when working with optical semiconductors
  • 30 m2 (330 sq.ft.) cleanroom ISO Class 8 for optics assembly

We guarantee quality by maintaining validated and standardized processes for

  • Purchasing
  • Assembly
  • Product configuration
  • Product calibration
  • End testing
  • Packaging and shipment

Our team consists of highly qualified specialists backed-up by an efficient organization and experienced management.

All engineers have years of experience in all relevant disciplines, including physics, optical engineering, mechanical engineering, electronics and software engineering. Miltenyi Imaging has manufacturing facilities and the complete infrastructure of a modern enterprise. Our manufacturing team is highly trained and specialized in building up and assembling precise mechanical, optical and electronical instrument components and devices. The technical support employees with biotechnology background are specifically trained to discuss the final application of customers and to consult finding the perfect instrumentation.

Our Partners

Miltenyi Imaging works with a number of partner companies to provide complete multiplexing and imaging solutions to its customers.