RegulatoryQualityCompliance

Navigation and Streamlining the Global Regulatory Arena!

(908) 809-0081


Available as needed after regular office hours | Hours of Operation: Monday – Friday: 8:00 AM – 6:00 PM

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    Pre-submissions510k Regulatory SubmissionsDe Novo Strategies21 CFR 820 Quality Management System DevelopmentFDA 483 Remediation StrategiesMock AuditsPre-market Approval Process
    EU MDR 2017/745ISO 13485:2016 QMS DevelopmentCE Marking
    Gap Analysis :
    MDSAP Audit Preparation
    MDL Submissions :
    Global Regulatory Strategy DevelopmentCorporate Regulatory/Quality Due DiligenceExpert Witness TestimonyNew Product Business DevelopmentMarketing StrategiesSpeaking EngagementsCorporate Training

    Global RQC Med Device Solutions LLC

    Hours of Operation Monday – Friday, 8:00 AM – 6:00 PM Available as needed after regular office hours.Address: Somerset, NJ 08873By Phone: (908) 300-3854By Email: jmonroe@globalrqc.com