ProstaLund

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 ProstaLund a half-day this week. The scope of the audit was the new platform CoreTherm™ Eagle. The audits yielded positive results with only one minor nonconformity.

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, ProstaLund hosted a combined surveillance audit of EU MDR 2017/745 & MDD 93/42/EEC, and recertification audit of ISO 13485 in February. Even this audit of TÜV SÜD was successful and resulted in only one minor nonconformity. The scope of the audit was the complete Quality Management System and product portfolio of ProstaLund.

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. ProstaLund stands strong and continues to prepare for the launch of CoreTherm™ Eagle” says Anders Kristensson, CEO of ProstaLund.