From startups to global manufacturers, MK Regulatory Services, LLC (MKRS) transforms complex regulatory requirements into clean, executable pathways: fast, confident, and compliant.
✨ Your device. Your roadmap. Done right the first time ✨
Strategic Leadership
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EUMDR / IVDR
FDA Q(M)SR
Health Canada
Global / OUS Frameworks
Audit-Ready Compliance
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QMS Builds
Design Control
Risk Management
MDSAP
Post-Market Surveillance
Market Access Acceleration
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Regulatory Submission Gap Analyses:
510(k) / De Novo
PMA
CE mark Declaration of Conformity
Custom
Solutions
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Class II / III Devices:
Product Development Planning
Product Discontinuation Market Strategy