RTEmd

RTEmd helps medical device, pharmaceutical and medical software companies eliminate the compliance gaps and time delays associated with FDA compliant software development and helps extend the life and compliance of deployed medical products.

Over 95% of our medical device projects are completed on-time and within budget. Over 90% of our customers return to engage us in additional software outsourcing opportunities…new product development, sustaining engineering, SQA services and quality/regulatory support.

ISO 13485 & ISO 9001 certified and 62304 compliant, with extensive clinical and FDA experience, RTEmd takes a disciplined approach to everything we do. From embedded software/firmware and real-time control software to connectivity, data management and mobile medical applications, RTEmd understands the processes and responsibilities of producing compliant code in a regulated environment.

RTEmd has over 30 years of successful experience with: in-vitro diagnostics (IVD), medical imaging, patient monitoring, surgical applications, laboratory equipment, ophthalmology, nephrology, diagnostic imaging software, drug delivery, POC, infusion pumps and therapeutics.

To learn more about our software development, sustaining engineering and quality/regulatory services, please contact us:

Phone 585.383.1290
email: [email protected]
www.rtemd.com

Company’s Keywords:

ivd, medical imaging, gap analysis, medical device software, product development, infusion pump software, verification, validation, in vitro diagnostics, sustaining engineering, compliance, diagnostic imaging, regulatory consulting, software quality assurance