Kitron - Contract Manufacturing Partner for Medical Equipment

Kitron is a leading international electronic manufacturing services (EMS) supplier, with operations in Norway, Sweden, Germany, Lithuania, China and the US, where manufacturing and related services are delivered to customers globally.

We provide contract manufacturing services for highly complex products in medium batches, from design and development to sourcing, prototyping and manufacturing of electronics and electromechanics. We deliver finished products to end-users.

Kitron has more than 50 years of experience in electronics manufacturing and has earned excellent references from global partners. We offer services through the total contract manufacturing value chain, as outlined below.

Development services for medical equipment, laboratory and in-vitro diagnostics equipment, and handheld electronic equipment

Until recently, Kitron had a large in-house design / development department, but made the strategic decision to outsource this part of the value chain. Kitron has established a network of highly qualified design / development partners in our local markets, enabling us to offer the full scope of development services needed for our total customer portfolio.

Kitron focuses on industrialisation, test and new product introduction, while outsourcing pure design / development tasks to our third-party development partners. The objective is to improve the complete offering to our customers by combining the strengths of Kitron with dedicated development environments.

Medical device component sourcing and logistics

We are experienced at selecting suppliers and components globally for medical equipment and systems, and have a deep understanding of lifecycle analysis and regulatory requirements.

New product introduction and development for medical devices

At our modern product introduction (NPI) centres we work in partnership with customers who may have prints and documentation but need prototypes to validate the design. We find solutions to improve the product and reduce lead-time and costs, before manufacturing starts.

Automatic assembly of medical devices

We offer automated assembly lines for PCBs, electronics, microelectronics, assembly and various system tests, system integration, repairs and upgrades, product marking, traceability and packing.

Medical device electronic manufacturing, electromechanical assembly and high-level assembly

We use modern equipment for electronic manufacturing, electromechanical assembly and high-level assembly (HLA). Ultrasound racks are fully tested – electronically, visually and functionally. The electronics design for electrocardiograph (ECG) systems allows multi-channel functioning for both the collection of data and its transfer to PC-based software.

Secure, flexible and sustainable contract manufacture of medical equipment

Our quality is ensured by the following certifications and compliances:

• ISO 13485:2003
• 21 CFR 820 QSR
• FDA approval for our sites in Norway, Sweden and Lithuania
• ISO 14001:2004
• ISO 9001:2000
• ISO/TS 16949
• AQAP 2120

We work in compliance with 5S, Lean, Six Sigma, PFMEA and Kaizen. We have security and controls in place to safeguard customers' intellectual property (IP) information. Our enterprise resource planning (ERP) system enables efficient response, inventory management and capacity, with a high level of trust and symmetry between Kitron's business model and that of the customer (schedule flexibility, mix / volume / complexity, etc.)

Our flexibility is a result of our experience in handling fluctuating manufacturing volumes without normative levels. Ours is a culture of dedication to continuous improvement. We are a solid long-term partner, committed to sustainable development.

Ultrasound and cardiology systems, respiratory / medical devices and lab / IVD

The main types of medical equipment that Kitron provides contract manufacturing services for are:

• Ultrasound and cardiology systems
• Respiratory / medical devices
• Lab / IVD

Our main references are GE Healthcare, Gambro, MAQUET, Cellavision, Getinge, St. Jude Medical, Sectra, Galderma, Laerdal, Mole Genetics and Nordiag, among others.