Linkedin page opens in new window Twitter page opens in new window Facebook page opens in new window Blog Search: Search MEDICAL DEVICES & LIFE SCIENCES Innovative Life-Saving Projects The Medical Devices and Life Sciences market constantly face the need to keep up with and manage emerging technologies and regulatory compliances, while competing for market share. Specializing in rapid product development and innovation of medical devices and other regulated industries, we have a successful track record of conceptualizing, designing, and verifying products while meeting the strict requirements for quality, safety, and reliability. Your Trusted Medical Devices & Life Sciences Engineering Partner Syncroness has developed a range of tailored engineering solutions specific to the medical device class II market that enable the design and development of medical devices, in vitro diagnostics, assembly, test, and calibration equipment, diagnostic equipment and wearable technology. With our systems approach, we can help you cut through the clutter to identify the minimum viable product (MVP) and develop a product roadmap that realistically meets market demand faster than typical expectations. We use a tailored, proven product development methodology to ensure that we provide the highest-quality solution quickly while meeting the toughest FDA regulations. From conceptualization through production planning for 510(k), we will focus our efforts on helping you meet your specific goals faster than traditional methodologies, all while focused on identifying and mitigating risk throughout the lifecycle. MEDICAL DEVICES DIAGNOSTIC EQUIPMENT DISPOSABLES WEARABLES Learn more about our services TRY A DIFFERENT APPROACH BREAKTHROUGH TO FINISHED PRODUCT You’ve struck on an innovative idea or made a scientific discovery. We can elaborate on your idea and turn it into a marketable product. EXCEL IN COMPLEX DESIGN Our teams love tackling problems that haven’t been solved before. From new product development technology to performance improvements, we are motivated by challenging problems. DESIGN FOR ENVIRONMENT From UX to durability, we can make sure the product hits the mark. SUBMISSION-READY DOCUMENTS Navigating the regulatory process for a medical device can be very complicated. We’ve helped many of our customers through it and can make sure that your submission process is smooth. New Product Development From Concept To Production Syncroness can help you reduce your time to market by employing our systems engineering services to complete projects for you or by integrating with your team to increase your capacity. Working with Syncroness gives you the benefit of access to our technical experts, increasing your capabilities. Product Development Process Experts Our Project Managers are skilled at directing projects to ensure that the planning and execution of projects meet your expectations. They collaborate with our Systems Engineers to capture all the relevant details related to your project, including requirements, behavior, architecture, risk, and testing of the system. Specifically, we specialize in: Conceptualization and feasibility studies Detailed design and development Agile hardware and software design process (including rapid prototyping) Verification and Validation planning, execution, and reporting Fabrication and Validation of clinical test units Supporting regulatory submission (FDA, CE, etc.) Transfer to manufacturing Enhancement and Maintenance Support for Existing Products When components go end-of-life or new functionality for existing products is required, we can help you make the necessary updates. Allowing us to take on these projects frees up your valuable internal talent to work on new product development, innovation, and research. Custom Automation Equipment to Meet your Assembly, Test, or Calibration Needs We are adept at the custom production development of equipment that allows you to save time and money by automating critical processes. We can also develop production equipment parallel with your product design, which can reduce total time and cost, and shorten your new product development time. CASE STUDIES Wearable Heart Monitor – Firmware LEARN MORE SYNCRONESS 10875 Dover St. Suite #500 Westminster, CO 80021 Tel: 303.429.5005 Fax: 303.429.5025 info@syncroness.com NAVIGATION Home About Us Services Markets Our Process Resource Center Careers Contact Privacy Policy RECEIVE EMAILS Stay up to date with everything Syncroness. SIGN UP ALL RIGHTS RESERVED AN ALTEN GROUP COMPANY