Case Study: Tamer Mölnlycke Care achieves audit-ready ISO 13485 compliance with Qualio

Impressing auditors and maintaining ISO 13485 compliance

Tamer Mölnlycke Care, a medical device manufacturer joint venture in Saudi Arabia, needed to launch with ISO 13485 accreditation and Saudi Food & Drug Authority certification but had no established quality system in place. The team wanted to avoid the pain of paper-based processes and create an audit-ready quality foundation from day one.

Qualio provided an electronic quality management system with pre-built medical device templates, guided implementation, document migration, training, and workflows for documents, events, CAPAs, and complaints. Tamer Mölnlycke Care went live in about one month, sped document approvals up 10x versus paper, cut approval time from a week to less than a day, and passed ISO 13485 and subsequent audits with confidence.

Tamer Mölnlycke Care

Omran Falemban

QEHS and Regulatory Manager