Comprehensive Quality Management
for Medical Device Development

Delivering great results through
disciplined processes

BVQi ISO 9001 CertifiedAt RTEmd, we believe that effective and compliant processes and procedures help us deliver outstanding results— quickly, consistently and cost-effectively.

That’s why we established quality software processes when we first opened our doors in 1981 and why we work hard to continuously improve them, year after year.

We have built our entire culture around our Quality Policy.

It governs every aspect of our business from sales, software development, and quality, to accounting and human resources. And every member of our team is required to follow it every day.

We're proud of our commitment to quality and of the fact that several of our clients have asked us to design and implement their quality systems and improve their internal development processes.

Here are some of the other reasons why you can expect quality when you trust your projects to RTEmd.

  • ISO-9001 Certification. Our highly efficient Quality Management System has been certified by BVC to be compliant with ISO-9001:2000. We are one of a few software service providers with this level of certification.
  • Software development process that incorporates critical process areas from CMMi. Our efficient development process incorporates the process areas and practices for the Software Engineering Institute's Capability Maturity Model for maturity levels 2 and 3.
  • Careful adherence to your quality standards. We will fulfill all of your quality requirements and expectations by following our internal processes or by employing your quality procedures.
  • Regular audits to ensure compliance. We conduct regular internal audits and Quality System management reviews to verify and document that we meet the required ISO and FDA quality standards and regulations. Our customers often audit our Quality System as well through their standard subcontract management process.
  • Risk analysis experience. Our team can lead the hazard analysis process, identify mitigation strategies, and document the results.
  • Final output in the format you require. No matter what quality procedures we employ for your project, you will receive detailed documentation with the right format and content.
  • A dedicated Quality Officer. Our Manager of Quality and Regulatory Practice helps us maintain compliance with our Quality Policy and our clients’ quality management systems.
  • Proven project management expertise. We combine our disciplined approach to quality with expert project management skills that facilitate and streamline the entire engagement. It’s all part of our effort to make outsourcing easy for you.
  • A sharp focus on proactive client communication. Our customer-focused engineers avoid problems and keep projects on track by keeping the lines of communication open with our clients.
  • Full accountability for results. We take full responsibility for every aspect of our assignment. So when you partner with RTEmd, you can count on us to deliver a quality product—right on time and right on budget.

For more information, contact us today.