Challenge: A global IVD manufacturer needed to achieve MDSAP certification to maintain market access in Canada, Brazil, Australia, and Japan, with a compressed 7-month timeline.

Solution: MDx deployed a team of QMS experts and former auditors to conduct a gap assessment, implement remediation, and conduct comprehensive mock audits across multiple sites.

Result: Successful MDSAP certification with only minor findings, achieved on schedule and maintaining uninterrupted global market access.