Regulatory & Compliance
Regulatory strategy, coordinated with specialist execution.
Federal oversight of laboratory-developed tests continues to evolve, alongside the EU IVDR transition and shifting CMS coverage policy. DMC keeps regulatory decisions coherent with the commercial pathway, and engages specialist regulatory, legal, and technical execution where required.
Practice areas
Regulatory, quality, and compliance capabilities.
- 01
Regulatory strategy
Enterprise regulatory strategy across CLIA, CAP, state licensure, FDA, and CMS pathways — and how each affects the commercial pathway. - 02
Readiness planning
Documentation and compliance roadmaps for laboratory-developed tests under evolving federal diagnostic regulation, plus MolDX and MAC coverage considerations. - 03
FDA & EU submission coordination
510(k), De Novo, PMA, CE-mark, and IVDR technical file work is executed by specialist regulatory counsel and consultants. DMC scopes the strategy, selects and coordinates the specialists, and keeps submission decisions aligned with coding, coverage, and commercialization. - 04
Quality systems
Quality management system design and remediation aligned with ISO 15189 and CAP requirements, coordinated with quality specialists where deeper technical execution is required. - 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 coordinates CLIA start-ups, CAP accreditation, quality systems, and inspection readiness, and brings in specialist regulatory counsel for FDA and EU submission work where required. We translate regulation into operating decisions.
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