Medical DeviceQualified Supplier Directory

RTEmd

160 Office Park Way
Pittsford, 
NY  14534  us
Tel: 585/383-1290, ext. 135
Fax: 585/383-1294

ISO 9001-2008—certified RTEmd provides outsourced software development and testing for complex medical equipment. For  30 years we've earned the respect of Abbott Laboratories, Beckman Coulter, IDEXX Laboratories, InfiMed, Ortho-Clinical Diagnostics, LipoScience, Welch Allyn, and many more.

New Product Development
Our services cover the complete spectrum of software development, from requirements analysis, architecture, and design, to helping you compile documentation for your Design History File and assisting with your regulatory submission.

Advantages:

  • Our experience means a short learning curve
  • We have a big-picture, whole-systems perspective: We develop software that interfaces seamlessly with all the other systems and components.
  • We scale our services to meet your needs. Whether you want us to manage the development of an entire system or a single module, RTEmd will provide the expert advice and turnkey assistance you need.
  • We help you define the right requirements: Yields accelerated time to market and reduced costs due to revisions
  • We meet tight deadlines
  • Extensive experience with highly complex medical devices
  • We create documentation that's ready for your Design History File.

Sustaining Engineering

Generate new revenue with software-driven enhancements to your existing medical equipment. Let RTEmd's Sustaining Engineering team help you to:

  • Add remote diagnostics
  • Update user interfaces or laboratory system interfaces
  • Support new peripherals
  • Increase throughput or performance
  • Reach a broader market

Medical Device Testing Services

Our skilled and highly qualified Quality Assurance department offers an end-to-end solution for your product testing needs, including:

  • Requirements Management and Traceability throughout the project lifecycle
  • Test Plan Development and Execution using industry-accepted automated tools, as well as customized manual solutions
  • Test Case creation that's compliant with customer and regulatory requirements
  • Quality Controlled Test Execution at the customer site or in our modern lab facilities
  • Full Array of Auditing and Qualification services, including SAT, IQ/OQ/PQ, ISO 9001-2008, and Internal/External Corporate Auditing
  • Software Process Improvement from Assessment and Recommendation to Design and Implementation of a Compliant Quality System