As per Medical Device Regulation (EU-MDR 2017/745), notified bodies are obliged to perform unannounced audits in the premises of manufacturers, its critical subcontractors or its crucial suppliers. TÜV SÜD therefore audited ProstaLund’s contract manufacturer one day, and
The audits primarily checked the extent of conformity of ProstaLund’s documentation for the new platform CoreTherm™ Eagle towards EU MDR 2017/745 and the Quality Management System standard ISO 13485:2016.
In addition to the unannounced audit,
Based on comparative annual data from 2023, the number of audit findings has steadily decreased, indicating sustained quality of systems made even better through improvements implemented.
“I’m very pleased with the results and the continuous improvements being made by the team.
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