A Unique Approach


We'll act as a commercially-minded extension of your team, taking lead on your project to get through the complex and ever-changing quality and regulatory requirements to be on market.

  • 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