CertHub automates regulatory compliance for medical device manufacturers through an all-in-one, AI-powered
software that simplifies QMS and technical documentation processes to bring products to market years faster.
CertHub solves the regulatory challenges of medical device manufacturers by automating processes and documentation with the AI-powered software platform: complex QM processes and structures, enduring inconsistencies and redundancies in technical documentation and high pressure during audits for medical device manufacturers.
With the digital quality management system (ISO 13485), processes come to life: the right colleagues are notified if necessary and verification documents are automatically created, which can be approved within the platform using e-signatures to include the latest content in the technical documentation. Medical device manufacturers are guided throught the initial certification and approval processes through the Certification Assistant to create the technical documentation according to the MDR or FDA 510k and submit it directly to the notified body. Thanks to the database solution, product information needs to be maintained only once, from which the required documents and reports for the notified bodies (e.g. technical documentation, medical device file) are created automatically (i.e. no redundant documents and content) – technical documentation with the press of a button!
With CertHub, more than 50% of the time and manual effort in quality management and regulatory affairs can be saved through the AI powered software platform, allowing medical device manufacturers to bring products to market years faster (risk class I, IIa, IIb, III) and ensure the long-term continious compliance of their products.
