STRATEC is a leading global provider of automation solutions in the field of in-vitro diagnostics and life sciences. With a strong focus on manufacturing excellence, we operate multiple state-of-the-art production sites for our instruments across Europe and Asia. These strategically located facilities ensure efficient, high-quality production to meet the diverse needs of our clients worldwide.
STRATEC’s commitment to quality is reinforced by comprehensive support systems that include rigorous quality control processes, adherence to international standards, and ongoing technical support for partners. With this approach, STRATEC consistently delivers reliable and innovative products that support the healthcare sector.
Partner with STRATEC and experience the power of proven technology, accelerated innovation, and unwavering commitment to your success.
comprehensive lifecycle management services for your diagnostics system
Your partner for product success
Your success is our priority. STRATEC offers end-to-end support, from initial development through to ongoing product care. We ensure your products meet evolving market needs and regulatory standards. At STRATEC, we are committed to your long-term success. Our comprehensive lifecycle management services ensure that your products are supported throughout their lifecycle. By partnering with STRATEC, you can focus on your core business while we handle the complexities of product lifecycle management.
Third-level technical support
STRATEC provides expert third-level technical support for instruments already operating in the field. Our dedicated team is ready to assist with troubleshooting, maintenance, and complex issue resolution.
Improvement Services
We offer continuous improvement services, collaborating with you to identify opportunities to cut costs and enhance performance, which also includes obsolescence management and feature extension options. STRATEC cooperates with its partners to utilize progress in production processes and implements value engineering projects to make this progress available for existing product lines.
Regulatory Compliance
For regulatory compliance we stay ahead of evolving regulations to keep your products compliant and market-ready.
Contract Manufacturing & Design Transfer
remain sustainably in the market
Once the instrument has been launched, STRATEC can assist its partners by providing a cost-effective and predictable way to remain sustainably in the market. Common issues solved include low reliability, obsolescence of critical components, maintaining compliance across regions, and managing seemly unpredictable costs. As part of the lifecycle transfer process, STRATEC will review the current technology and known issues, as well as identifying other potential watch-outs.
Parts of the design are revised and others retained to achieve the optimal balance of predictability, regulatory impact, engineering costs, and time to market. Partners stand to benefit from the full range of services STRATEC offers to support the system over its future lifecycle.
Engage with STRATEC for a Lifecycle Transfer Project
The most frequent points in the lifecycle to engage with STRATEC are:
After the initial launch of the first-generation instrument, when performance, reliability, and supplier predictability may not be adequate
Later in the lifecycle to address obsolescence and regulatory issues, when the future of the product is being considered, and cost management is paramount
Quality Management
quality, process excellence, and reliability
We believe a strong focus on quality, process excellence and reliability, together with an unwavering commitment to customer needs, creates the foundation for best-in-class commercial service.
INSTRUMENTATION MANUFACTURING SITES
At STRATEC, we optimize system development and production between our German, Swiss, and Hungarian facilities, ensuring high-quality, cost-effective solutions. Our ISO-certified, FDA-registered sites in Birkenfeld, Beringen, and Budapest supply spare parts, provide repair services, and manage manufacturing risks. We outsource module production to certified suppliers, maintaining high standards through rigorous validation and audits.
STRATEC assembles, tests, and delivers complete systems, including lab tests mimicking real-life performance needs. Our commitment to quality extends to supplying consumables, maintenance parts, and repair services, ensuring your success and regulatory compliance. From developments at STRATEC, to manufacturing transfer of existing products, through to re-designs and optimizations, we can provide you with the fitting solution for your series instrument.
STRATEC SE
GERMANY
STRATEC Switzerland AG
Switzerland
Diatron MI Zrt.
Hungary
stratec biomedical co., ltd.
shanghai, china
Birkenfeld, Germany
Manufacturing of small, medium-large, and large IVD instruments
Additional services, such as spare part supply and repair service
ISO9001 and ISO13485 certified
FDA-registered and regularly audited
Beringen, Switzerland
Manufacturing of medium-large and large IVD instruments
Additional services, such as spare part supply and repair service
ISO13485 certified
FDA-registered and regularly audited
budapest, hungary
Manufacturing of medium-large and large IVD instruments
Additional services, such as spare part supply and repair service
ISO9001 and ISO13485 certified
FDA-registered, CE-marked and regularly audited
shanghai, china
Manufacturing of medium-large, and large IVD instruments
Frequently Asked Questions
- What manufacturing capabilities does STRATEC offer?
STRATEC offers manufacturing for IVD instruments, including small, medium-large, and large systems. The best production site for the instrument is selected depending on instrument size, numbers, and production complexity.
- What does STRATEC provide beyond manufacturing?
In addition to manufacturing, STRATEC offers spare part supply, repair services, third-level technical support, and lifecycle management services.
- How does STRATEC ensure product quality during manufacturing?
STRATEC uses rigorous quality control processes, ISO-certified and FDA-registered sites, and regular audits to maintain high standards.
- What is included in STRATEC’s lifecycle management services?
STRATEC provides improvement services, obsolescence management, feature extensions, regulatory compliance support, and technical support for products in the field.
- Can STRATEC take over existing products for manufacturing transfer?
Yes. STRATEC can support development transfers, manufacturing transfers, redesigns, and optimizations for series instruments.
- Which production sites are ISO-certified or FDA-registered?
The STRATEC production sites Birkenfeld (Germany), Beringen (Switzerland) and Budapest (Hungary) are ISO-certified and FDA-registered.
