Regulatory & Compliance
Practical regulatory strategy for a changing landscape.
FDA's LDT final rule, EU IVDR transition, CMS coverage evolution, and heightened enforcement have made regulatory readiness a board-level priority. DMC provides both strategic direction and hands-on execution across US and European submissions.
Practice areas
Regulatory, quality, and compliance capabilities.
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Regulatory Consulting
Enterprise regulatory strategy across CLIA, CAP, state licensure, FDA, and CMS pathways. - 02
FDA & CMS Readiness
LDT phased compliance roadmaps, IVD submissions, MolDx and MAC coverage strategy. - 03
FDA & EU submissions
510(k), De Novo, and PMA submissions with the FDA, and CE-mark and IVDR technical file preparation for the European market — coordinated as a single global regulatory strategy. - 04
Quality systems
Design and remediation of quality management systems aligned with ISO 15189 and CAP requirements. - 05
Inspection preparedness
Mock inspections, corrective action programs, and audit response for CAP, CLIA, and FDA. - 06
Compliance program
OIG-aligned compliance program design, monitoring, and training for diagnostic laboratories.
Point of view
The laboratories that treat regulatory as a strategic asset — not a compliance cost — will define the next decade of diagnostics.
DMC's regulatory team has led CLIA start-ups, CAP re-accreditations, FDA 510(k) and De Novo submissions, EU IVDR and CE-mark filings, and MolDx coverage packages. We translate regulation into operating decisions.
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