Medical Devices Document Management

Medical devices companies face the task of meeting all FDA regulatory requirements including ISO 13485, 21 CFR Part 11, and other ISO compliance standards. From design conception to clinical trials to robust manufacturing of medical products, introducing electronic document control management to this market is often a long, involved process. Visidian Connect allows medical companies to stay on top of regulatory requirements while producing safe and effective products. Visidian Connect’s robust workflow system automates a company’s design and change processes allowing users create documents and approve them with electronic signatures. Visidian Connect keeps an entire history for the product to ensure a complete audit trail.