Case Study: Wetling achieves rapid paper-to-cloud eQMS migration and ISO 13485:2016 certification with qmsWrapper

Wetling - Customer Case Study

Wetling, maker of the Wetling W200 wound‑healing device using WMCS, faced the dual challenge of upgrading its Quality Management System from ISO 13485:2003 to ISO 13485:2016 and moving from a paper‑based QMS to an online eQMS. After evaluating five options, Wetling selected qmsWrapper for its medical‑device focus, integrated modules (DMS, risk management, Interactive Quality Manual, QMS Workflow) and the vendor’s hands‑on support.

qmsWrapper delivered a cloud‑based eQMS with remote configuration and two weeks of preparatory work followed by onsite training, enabling Wetling to complete the migration in a couple of weeks. Immediately after implementation Wetling was audited by TÜV SÜD (the auditor’s first exposure to qmsWrapper) and was issued the new ISO 13485:2016 certificate; one year later Wetling reports heavy use of qmsWrapper’s DMS and ongoing benefits from the vendor’s support, faster digitalization, and improved document control.

Wetling

Anders Berglund

Chief Executive Officer