In Vitro Diagnostics

Speeding up your time to market with experience and expertise

RTEmd has been helping major clinical lab manufacturers launch new products and improve existing ones for more than 25 years.

We've developed software for virtually all of the elements in these highly complex devices — from precision sample metering, mechanical motion, and instrumentation, to user interfaces, connectivity, and remote diagnostics.

Our expertise in in vitro diagnostics, combined with our capabilities in diagnostic imaging, means that we're well positioned to help our clients realize the full range of opportunities associated with targeted medicine and the trend toward providing a complete diagnostic picture. Also, our broad experience enables us to provide solutions that address the needs of both clinical and radiology labs as they increasingly merge.

Our engagements have ranged from small, focused assignments to multi-million-dollar projects, and we've developed a reputation for delivering on time and on budget, thanks to our proven quality and project management expertise.

Here is why major manufacturers keep coming back to RTEmd:

  • An accelerated learning curve. Thanks to our extensive experience with clinical laboratory diagnostics projects, we know how to get up to speed quickly, and we work hard to add value from Day One.
  • New product development and sustaining engineering expertise. We can help you launch new products. We can also extend the life of products already operating at customer sites with new features, improvements, solutions for obsolescence, manufacturing cost reduction, and on-going support.
  • A portfolio of services covering the entire software lifecycle. We streamline development from concept to deployment, including software architecture and design, implementation, verification & validation, expert documentation, and more.
  • More than 25 years of FDA experience. Our extensive experience and adherence to process help clients in the U.S. meet demanding regulatory requirements.
  • A proven commitment to quality. We have an ISO 9001-2000 certified Quality Management System because we know that a disciplined and efficient approach to quality saves our clients time and money.
  • A flexible, customer-focused approach to development. Our software development process is remarkably efficient because we have continuously improved it over the past 25 years. But we can also adopt your processes, procedures, and terminology.
  • Expert documentation skills. Thanks to our proven expertise in documentation, you’ll get detailed information in the format you need for your Design History File (DHF) and FDA submissions.
  • Extensive engineering resources. We can respond quickly to changing requirements and project schedules because we have a staff of more than 40 full-time engineers and technicians.

These proven strengths help us turn single projects into long-term partnerships.