EUDAMED Exclusive Client Reveal: How Santex Spa Secured MDR Compliance
Veronica Bartolini
Claudia Di Domenico
Nicolas Lavergne
Key Takeaways from the Webinar
Join our webinars to explore the latest regulatory compliance strategies in the medical device industry. Our experts provide practical solutions and answer your questions live.
Manual data entry is highly resource-intensive
Entering 50 to 55 specific data fields manually for a large volume of product codes can consume a full year of a resource’s working time
EUDAMED lacks error debugging
The native EUDAMED interface does not provide a debug system, making the manual process highly vulnerable to unnoticed human errors
Mass data import via simple templates
Acomas simplifies compliance by providing an easy-to-use, auto-updated Excel template that allows companies to upload and edit massive volumes of data seamlessly
Automated regulatory alignment
The Acomas software automatically updates in sync with EUDAMED changes, relieving manufacturers from the burden of constantly monitoring the database for new requirements
Valuable QA/RA expertise
Beyond the software, Acomas provides essential regulatory support to help clients navigate complex mandatory fields for different device classes and correctly format specific data
Comprehensive onboarding and IT support
Clients receive step-by-step guidance, including IT support for system integration and full QA documentation necessary for software validation and quality management
Meeting timelines without extra resources
By automating the data upload process, companies can successfully meet strict regulatory deadlines without the need to hire additional staff
Built-in data validation
The Acomas software includes a debugging feature that ensures data quality by preventing the upload of wrongly written information to EUDAMED
Audit-proof traceability
The solution tracks all data manipulations and synchronizations perfectly, which can reduce the EUDAMED data synchronization portion of a painful audit to just 5 to 10 minutes
Scalable to global databases
The platform is built for long-term governance, allowing manufacturers to manage other global regulations like FDA GUDID and the upcoming Swissmedic database within a unified system
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Compliance guidance for your team
Practical resources to prepare for audits, structure your UDI data, and manage multi-market registration