Medical Device Software Services

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Medical Device Software Services

  1. 1. .000000000000000000000387590164346457900114614880002 . 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 38 75 9 0 16 4346 45 79 0 0 1146 148 8 0 0 0 2 SUSTAINING ENGINEERING VERIFICATION AND VALIDATION NEW PRODUCT DEVELOPMENT LEADING INNOVATION MISSION CRITICAL EXECUTION 000000000000000000000387 5901 64 3 4 6 4 5 7 9 0 0 1 1 4 6 1 4 8 8 0 0 0 2 4 6 8 008 8 76 25 2
  2. 2. .00000000000000000000038759016434645790011461488000246 WELCOME TO THE WORLD of RTEmd …where promises are kept and deadlines are met We know that your business .00000000000000000000038759016 depends on the quality, reliability, and safety of your mission-critical medical devices. 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 .00000000000000000000038759016434645790011461488000246800887 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. .00000887 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. .00000887 LIVES DEPEND ON THE MEDICAL DEVICES YOU MANUFACTURE. .0000088700 .0000000000000000000003875901 .0000000000000 29
  3. 3. 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 IDEXX Laboratories • 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. Regulation (QSR). 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. audits. .0000000000000003875901643464579001146148800024680088762524 .00000495816373898899200023572057657
  4. 4. .0000001148 INNOVATION + DISCIPLINED EXECUTION = repeat performances In a highly specialized business like medical Our clients recognize the value of forming a long- device software services, it’s easy for outsourcing term relationship with a dedicated, full-spectrum providers to focus on their technical expertise. But resource, one that can help them innovate. from our perspective, that’s just the starting point. They know that long-term relationships lead to efficiencies and a healthier bottom line. That’s At RTEmd, we go well beyond simply executing. why many of them come back to us again and We have established peaks of expertise that lead again for repeat engagements. to genuine innovation. Some of our in-house experts have clinical laboratory backgrounds. We focus so diligently on managing relationships Some possess specialized engineering skills. Still with our customers that successful results are the others intimately understand how to work with only possible outcome. That’s how we turn first- 000000000000003875901643464579 00000000000003875901643464579001146these talented the FDA. The participation of time projects into long-term partnerships 464579001146 on-staff professionals guarantees both a smooth that deliver maximum value. 08876609 process and superior results. QUALITY underlies everything We established rigorous quality processes when we WHY WORK with RTEmd? first opened our doors, and have worked continuously to improve them. Some of our clients even ask us to WE MAKE OUTSOURCING EASY design and implement their quality systems and We handle everything from small, focused improve their internal development processes. assignments to multi-million-dollar engagements. COUNT ON US FOR: No matter the size, we approach your project with 160 Office Park Way a spirit of enthusiastic, focused cooperation. • ISO9001:2000 certified Quality System Pittsford, NY 14534 managed by a dedicated Quality Officer phone 585.383.1290 Learn more about our services and our proven • SEI Capability Maturity Model. Our software fax 585.383.1294 processes by visiting our web site at development process incorporates critical www.RTEmd.com or contacting us by process areas from CMMI www.RTEmd.com email at solutions@RTEmd.com. • Adherence to your quality standards • Product hazard analysis and mitigation • Detailed documentation to support FDA submissions and audits • Verification testing throughout the development process ©2007 Real Time Enterprises, Inc. All rights reserved.

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