Our priority #1

Quality is fundamental to everything we do at Fujirebio. Our customers and partners must be able to fully trust the consistency and stability of any of our products.

With over 50 years’ IVD experience, we understand the vital importance of quality issues and how they affect every step of the research, development and manufacturing process. Above all, as a global supplier, we align ourselves with the requirements of local, regional, and national regulatory bodies around the world.

Quality policy

We want to provide our customers with products and services which:

Meet customer expectations
Comply with the quality and regulatory requirements for the use for which they are developed, manufactured and distributed
Are effective, safe and reliable (risks are identified, minimized and controlled during the whole product life cycle)

We actively promote a strong focus across our global organization on quality, including ongoing maintenance, management, and improvement of our quality systems.

All processes involved across the entire life cycle of our products, from concept through design, manufacturing, distribution, installation and servicing follow the ISO 13485 quality management system for medical devices.

In addition, all of our locations have quality teams who work together to deliver high quality products whether that be for CDMO (OEM) partners or for our own products.

Lumipulse G B·R·A·H·M·S PCT Chemiluminescent Enzyme Immunoassay (CLEIA) Datasheet

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