Our Approach


At MDC we take a very collaborative approach to working with clients and we manage our projects to our clients’ needs, timelines and schedules. We understand that your ultimate goal is commercial success, and MDC’s services and approach are geared toward getting you to that point quickly and efficiently.

  • Regulatory
    Affairs

    • Regulatory strategy & guidance
    • Pre-submission and FDA meeting support
    • 510(k), de novo, PMA FDA submission
    • CE-mark (MDD/MDR, IVDD/IVDR)
    • Health Canada license
  • CRO
    Services

    • Study Design and Protocol Development
    • Site selection, contracting and IRB
    • Study management, monitoring, auditing
    • EDC development and testing
    • Data management, monitoring and auditing
    • BIMO audit support
  • Quality
    Systems Compliance

    • QMS development, implementation and training
    • Gap Audits (US FDA QSR, ISO 13485:2016, MDSAP, ISO 9001:2015)
    • Certification support and audit management for ISO, MDSAP, IVDD/IVDR and MDD/MDR
    • Internal Quality Audits (IQA)
    • CAPA audit and implementation
    • FDA inspection and warning letter support
  • Point-of-Care Analyzer Remote Training

    • CLIA waiver and Moderately Complex Analyzers and Tests
    • Training program and material development
    • Life video remote user training
    • Performance Verification: protocol development, data entry & analysis, PV reports
    • Software and product updates training
  • Market Research / Marketing Support

    • Market research reports
    • Advisor Boards
    • Voice-of-Customer surveys and phone interviews
    • Thought-leader introductions
    • Product launch and Go-to-Market strategies
    • Facility and contact lists
  • Applications / Product Areas

    Applications

    • Microbiology
    • Infectious Diseases
    • Clinical chemistry
    • Endocrinology
    • Diabetes
    • Women’s health
    • Hematology
    • Oncology

    Product Types

    • Point-of-Care Test
    • Molecular Diagnostics
    • Single-plex PCR
    • Syndromic panels
    • Antimicrobial susceptibility testing
    • Culture media
    • Mass spec/MALDI
    • Immunohistochemistry
    • Microarrays
    • FIT assays

Let's Talk