Case Study: Tamer Mölnlycke Care achieves ISO 13485 compliance and audit success with Qualio

Tamer Mölnlycke Care gets audit-ready in 1 month with Qualio

Tamer Mölnlycke Care, a medical device manufacturer based in Saudi Arabia, faced the challenge of needing to quickly achieve ISO 13485 accreditation and SFDA certification as a new company with no existing quality system. Their QEHS and Regulatory Manager sought an electronic quality management system (eQMS) from the beginning to avoid the difficulties of suboptimal document processes and to establish a strong foundation for compliance.

The company selected Qualio as its eQMS solution for its medical device expertise and flexibility. With Qualio's pre-built templates, Tamer Mölnlycke was fully operational within a month. The results were immediate, with document approval times cut from a week to less than a day. They passed their ISO 13485 audit with flying colors, with auditors specifically praising Qualio for the speed and ease of document retrieval and review.

Tamer Mölnlycke Care