Manufacturing
We manage the full, regulated production of your complex devices. Our global facilities offer end-to-end assembly, from circuit boards (PCBA) to final system integration, reinforced by integrated testing and adherence to global quality standards. This delivers predictable quality and reliable supply at scale.
Plexus provides full-system manufacturing for highly complex life science instruments in ISO 13485-certified facilities:
- End-to-End Manufacturing: We handle everything from high-complexity printed circuit board assemblies (PCBA) to final system-level assembly (High-Level Assembly, HLA) and complete box-builds.
- Integrated Test and Inspection: We implement comprehensive, validated testing and inspection protocols throughout the assembly process—not just at the end—to guarantee the uncompromising performance and safety of every device.
- Fulfillment and Logistics: Beyond manufacturing, we manage secure storage, packaging, regulatory labeling, and the global distribution of your finished products, ensuring they reach end-users efficiently.
Technology readiness levels: A framework to help accelerate life science instrument development
Critically evaluating the commercial readiness or maturity of technology for a life sciences product can be challenging. Plexus has found great value in using the Technology Readiness Levels (TRL) framework to help scope life science instrument development projects, build alignment, identify risks and bring clarity to life sciences project management.
Quidel Sofia 2 Fluorescent Immunoassay Analyzer
In this case study, Plexus showcases how it worked with Quidel, a leader in diagnostic healthcare, to rapidly scale production of the Sofia® 2 fluorescent immunoassay analyzer to support increased demand for point-of-care testing devices used in the fight against COVID-19.
Is your life science technology ready for manufacturing?
Product development is complex, and it’s crucial to consider key factors that can prevent manufacturing delays.
In this article, Plexus outlines how to build a successful product, develop a strategy for supply chains and implementation of manufacturing tests, and how the Plexus product development process can support you in the timely launch of life-changing products.
Thermal cycling for a point-of-care molecular diagnostics instrument
In this case study, Plexus showcases how it supported a major molecular diagnostic OEM to develop a custom solution. Find out how Plexus supported the successful commercial introduction of MDx solutions to enable better healthcare outcomes.
Three key considerations to ensure a reputation for life science innovation
Life science technology demands fast-paced innovation. In this article, Plexus outlines the keys to staying at the forefront of life science product innovation, including how the right partner can cement your place as a leader in life science innovation.
Smart engineering strategies to future proof your system development
Wednesday, February 18 at 16:00 GMT | 17:00 CET | 11:00 EST | 08:00 PST
Join us for an in-depth session exploring the essential framework that guides life sciences and MedTech products from early scientific concept to sustained, high-volume production. We unpack the critical differences between R&D/assay development and production-ready medical projects, showing how an engineering-led approach anticipates the complexities of regulatory demands, scalability challenges, and long-term data capture.
Learn where early, strategic collaboration creates a decisive competitive advantage, and how addressing the non-obvious challenges early can mean the difference between a promising breakthrough and a reliable, profitable commercial product.
Key learning objectives:
- Recognize and adapt to the fundamental differences between scientific discovery (assay development) and product development (regulatory requirements).
- Understand how early engineering collaboration ensures the instrument development (hardware/software) supports and accelerates potential changes in the assay and data analysis.
- Identify the critical, non-obvious manufacturing and supply chain focus areas that must be addressed early to guarantee a smooth, successful product launch.
- Learn how to leverage Plexus's full-cycle expertise to transform a scientific concept into a high-quality, scalable, and commercially viable product.
Who should attend?
This event is perfect for individuals working in:
- Product & strategy management
- R&D
- Engineering & technical
- Quality & regulatory
- Assay development
Certificate of attendance
If you attend the live webinar, you will automatically receive a certificate of attendance, including a learning outcomes summary, for continuing education purposes. If you view the on-demand webinar, you can request a certificate of attendance by emailing editor@selectscience.net.













