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.
Challenge: A Class IIb medical device manufacturer received major nonconformities related to risk management during their MDR surveillance audit, threatening their certification status.
Solution: MDx conducted a comprehensive risk management file review, facilitated new risk analysis sessions, and implemented a revised ISO 14971:2019-compliant risk management process.
Result: All nonconformities closed within the required timeframe, with MDx’s approach receiving positive feedback from the Notified Body for its thoroughness and compliance.
Challenge: A precision medicine startup with limited resources needed to establish an ISO 13485-compliant QMS to support CE marking of their first advanced NGS diagnostic test under IVDR.
Solution: MDx implemented a staged QMS development approach, prioritizing key processes needed for immediate regulatory requirements while building a scalable framework for future growth.
Result: ISO 13485 certification achieved within 6 months with zero major nonconformities, enabling the client to proceed with IVDR technical documentation submission on schedule.
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