Quality Standards

Fortis Life Sciences takes pride in delighting our customers. Quality is the job of every Fortis employee throughout the entire product lifecycle. Our highest priorities are:

  • Developing and delivering superior products and services to meet our customers’ requirements with reliable, responsive customer and technical support,
  • Complying with applicable regulatory requirements,
  • Continually improving our products and processes,
  • Maintaining the effectiveness of our site Quality Management Systems, and
  • Providing scalable supply chain assurance for our customers.

Montgomery Office – Bethyl Laboratories

Protein Division

Bethyl Laboratories, Inc. has been dedicated to improving lives by supporting scientific discovery through its qualified antibody products and custom polyclonal services since its founding in 1972. Bethyl has a global reputation for quality, consistency and first-class customer care. Every antibody that Bethyl sells is manufactured to exacting standards in Montgomery, Texas, and is validated in-house by a team of scientists. From the veterinary facilities to the development, production, and validation labs, the entire Bethyl team focuses on delivering quality products and delighting customers.

View recent inspection certificates:

San Diego Office – nanoComposix

Diagnostic Division

Founded in 2004, nanoComposix, is headquartered in San Diego, CA, USA. nanoComposix was built with the mission of providing precisely engineered and highly characterized nanomaterials to a global customer base. The product portfolio contains hundreds of different variants of materials, size, shape, and surface backed by extensive technical documentation and support. Development services are provided by a technical team with extensive expertise in nanotechnology, biology, chemistry, physics, and optics. nanoComposix produced the NIST nanosilver reference material and its materials have been utilized in over 3000 peer-reviewed publications. nanoComposix is an ISO 13485 certified* company. This helps to ensure that our products and services are of the highest quality and continue to meet customer expectations.

ISO 13485:2016 Certification for Quality Management System

*For products within the scope of our ISO certification.


Grand Rapids Office – Empirical Bioscience

Genomics Division

We meet the stringent requirements of the research, clinical, and life sciences industries. Our Quality System (QS) is an integral part of everything we do.

All Empirical Bioscience products are developed and manufactured in our facilities under the most rigorous requirements of ISO 13485:2016 from early-stage development, technology transfer through manufacturing scale up, validation and full production.

Our Quality System provides validated and fully documented manufacturing procedures, a certified, traceable supply chain, reproducible products and processes, complete lot traceability, and order tracking.

Empirical assures you of scalability with consistent quality, from development through OEM product manufacturing. Whether you need a standard product, a private label product, a custom manufactured product or a custom kit, we will deliver at the highest quality and the lowest total cost.

Our facilities are FDA registered as manufacturers of Reagents for Molecular Diagnostic Applications. Therefore, virtually all products manufactured in our facility are suitable for use as materials in a wide range of applications, from research, to high-throughput testing and IVD applications.

Our systems approach to products and manufacturing assures that you can have the highest confidence that your quality requirements will always be met at the lowest total cost.

Benefits of ISO Quality System

  • Validated Manufacturing Procedures
  • Fully Documented Manufacturing
  • Certified and Traceable Supply Chain
  • Reproducible Products and Processes
  • Complete Lot Traceability
  • Order Tracking

ISO 13485:2016 Certification for Quality Management System

ISO 13485:2016 Certification for Quality Management System - Per Site

ISO 13485:2016 Certification for Management System - Medical Devices

ISO 13485 Supplier Quality Agreement