Many medical device companies have expanded rapidly in both size and scope of products that improve peoples’ lives, but has their product data management system kept up with their growth? It is not uncommon for companies to continue to take an ad-hoc approach, using Excel in many cases, to manage product data. However, they tend to experience errors related to Bill of Material (BOM) accuracy and a lack of data continuity across different functions, such as design, quality and manufacturing creates a challenging environment for traceability and regulatory compliance. To eliminate these barriers to growth, companies are seeking access to the latest tools and processes that support digital continuity and collaborative processes. Savvy companies that optimize product data management and shorten the time to market will have the advantage.
Discover in our customer story below how Osstem Implant embraced a digitally driven transformation of their business processes in order to ease the compliance and quality challenges they faced.
Quality Management enables medical device companies to overcome obstacles to consistency, including information silos, inefficient manual processes, compromised data integrity and unconnected legacy systems. Providing complete management of the entire event lifecycle, this comprehensive solution is designed to help medical device manufacturers expand programs to best capture a wide scope of operations intelligence, which can drive continuous improvement and streamline their quality processes.
Design Control and Development DMR allows medical device companies to automate and effectively manage the compilation of records containing procedures and specifications required to manufacturer the finished device to help ensure compliance with FDA regulations, ISO quality standards, and other global regulatory requirements into a single, centralized, secure repository.