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ivdwise skip to content home validation workflow datancia com home validation workflow datancia com the wise way to make expert ivd validation smooth clsi guided validation workflow platform designed for ivd companies one platform for the entire validation lifecycle ivdwise guides your team through the full clsi evaluation protocol workflow from experiment design and execution to statistical analysis report generation and final sign off structured clsi ep driven workflows help ensure every requirement is met consistently without second guessing or gaps built for the regulations that govern your business ivdwise automates statistical analysis structures regulatory documentation and standardizes validation procedures to meet leading ivd regulatory requirements including eu ivdr 2017 746 and us fda 21 cfr part 809 compliance is built into every step not added at the end expert knowledge embedded in your process ivdwise was developed by a multidisciplinary team of academics professional statisticians and industry experts with decades of hands on experience in ivd validation advanced statistical modeling and scientific software development their expertise is built directly into the platform s logic guardrails and workflow design less time on compliance more time on innovation when validation becomes guided and automated scientists and r d teams spend less time producing documentation and more time generating evidence solving technical challenges and advancing product development ivdwise shortens timelines and helps differentiated products reach the market faster the real cost of validation is not the software the cost of ivdwise is quickly offset by lower internal labor costs faster study completion fewer review cycles and reduced risk of repeating experiments due to protocol or reporting errors based on a two year model covering one clsi workflow and three routine studies per year ivdwise reduces labor costs by 47 products ivdrift analyze ann ensure compliance in ivd product validation and verification with our software designed to automate statistical analysis customize regulatory reports and standardize procedures to meet rigorous european ivd regulations discover more ivdrift regulate ai regina generate compliant documentation with our ai powered tool which compiles verifies and organizes data from diverse sources into comprehensive reports streamlining collaboration and ensuring regulatory accuracy discover more ivdrift check ai chelsea provide a thorough final review pinpointing any areas that require attention for eu 2017 746 compliance so you can submit your technical documentation with confidence coming soon a team of experts our software is developed by a dedicated team of professionals from both academia and industry bringing together extensive expertise in statistics regulatory compliance and applied problem solving with a deep understanding of real world challenges our team is uniquely equipped to bridge the gap between cutting edge research and practical solutions for ivd manufacturers in addition to building the software we offer on demand consultancy services combining our educational spirit with regulatory insight to help address your specific needs with precision and clarity our origins the wise way to make expert ivd validation smooth quick links home terms and conditions privacy policy cookie policy eu home terms and conditions privacy policy cookie policy eu get in touch hello ivd wise com c saragossa 47 1r 08006 barcelona phone 34 630 725 232 ai assisted highly compliant technical documentation preparation for ivd medical devices quick links home terms and conditions privacy policy cookie policy eu home terms and conditions privacy policy cookie policy eu get in touch hello ivd wise com c saragossa 47 1r 08006 barcelona phone 34 630725232 manage consent to provide the best experiences we use technologies like cookies to store and or access device information consenting to these technologies will allow us 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