WELCOME TO THE WORLD of RTEmd
…where promises are kept and deadlines are met
We know that your business
depends on the quality, reliability,
and safety of your mission-critical
Our experts — in software architecture,
systems engineering, and veriﬁcation and
validation — work at the frontiers of innovation.
They lead project teams that bring decades of
experience in medical device software services
to their work for today’s leading manufacturers.
Our highly skilled project management staﬀ
ensures that every last detail is covered during
each stage of development — from concept to ﬁnal
delivery. Our managers see that all requirements
are addressed and all FDA regulations are satisﬁed.
Along the way, you’ll ﬁnd that we’re ﬂexible,
proactive, and easy to work with.
Helping our clients bring their products to
successful completion is only part of the equation.
We know that time to market can spell the
diﬀerence between proﬁt and loss, success and
failure. At RTEmd, we focus relentlessly on your
time to market, and we will never compromise it.
WE KNOW THAT
That’s our pledge to you.
ON THE MEDICAL
OUR CORE FOCUS: medical devices
We concentrate solely on the medical device industry, where our expertise runs deep and where we’re able
to provide superior value. RTEmd has the experience to help create fully integrated product lines – bringing
together in vitro diagnostics, in vivo imaging, and healthcare information technology.
“There are no surprises
IN VITRO DIAGNOSTICS DIAGNOSTIC IMAGING
with RTEmd. They’re
We’ve been helping major IVD manufacturers launch We have more than 10 years of experience in
new products and improve existing ones for more than developing specialized software solutions for
intuitive and they ask all
25 years. This extensive experience enables us to get demanding, innovative manufacturers in the
the right questions. They
up to speed quickly on your project. diagnostic imaging market.
bring solid design options
Our software development process is remarkably We can help you take advantage of exciting
to the table and their
eﬃcient because we’ve been continuously reﬁning and opportunities in:
improving it from the very beginning. But we can also
teams become one with
• Image analysis and post processing
adopt your processes, procedures, and terminology. It’s
• Computer-aided diagnostics ours. We trust them.”
all part of our eﬀort to make outsourcing easy for you.
• Instruments for automated testing
Our capabilities cover virtually all of the elements in —Don Kennel,
• Workﬂow analysis and automation
highly complex IVD devices – from precision sample
• Teleradiology and remote diagnostics
metering, mechanical motion and instrumentation to
user interfaces, connectivity, and remote diagnostics.
FROM CONCEPT Our services cover the complete spectrum of software SUSTAINING ENGINEERING
development, from requirements analysis, architecture,
TO COMPLETION , There is often additional revenue available, as well as
and design, to helping you compile your Design History
AND BEYOND : we longer-term value for your customers, in your existing
File, all the way to assistance with your regulatory medical devices.
cover the full spectrum submission.
of medical device Our sustaining engineering services – along with a
proprietary project management process – provide a
product development VERIFICATION & VALIDATION
turnkey solution that lengthens the value cycle of your
RTEmd’s testing, veriﬁcation and validation services
We have the breadth and depth of experience to current products. Our process enables us to plan and
ensure that your software does what it’s designed
quickly understand your culture, your technology, execute a smooth transition of responsibility to our
to do and that it protects the safety of operators and
and your objectives. We’ll partner quickly with your team for ongoing support, bug ﬁxes, and enhancement
patients. Our extensive FDA experience helps you
internal team and help generate results as soon as of your products.
comply with the requirements of the Quality System
we’re on board, adding value from Day One.
NEW PRODUCT DEVELOPMENT We’ll help you analyze requirements, develop design
documentation and comprehensive test plans, and
Our thorough understanding of medical device
conduct code reviews. Our dedicated quality assurance
development accelerates time to market and prevents
team will execute test plans and conduct compliance
costly revisions before, during, and after launch.