STRATEGIC APPROACHES

There are many aspects to successful market entrance for new diagnostic tests?any device that successfully passes through the US FDA pre-market review was designed to meet that goal. Whether your test design meets FDA clearance criteria before or after your initial submission is up to you.

At best, a declined submission means many months of costly studies and rewrites, and repeating the lengthy review cycle of resubmission. At worst, it means loss of a product and its related costs. We help ensure that your device submission is acceptable to the US FDA.

  • Strategic Planning from Concept to Market
  • Premarket Notification 510(k) Submissions
    • New products
    • Product/process changes
    • New intended uses
  • Premarket Approval Applications (PMA)
    • New applications
    • Amendments/Supplemental applications
  • Investigational Device Exemptions
    • IDE/pre-IDE submissions
    • Clinical Protocol development
    • Annual Progress Reports
  • CRO Services
    • Clinical Site identification/qualification
    • Training, Monitoring and Close Out
    • Data management
    • Data Collection
    • Statistical Evaluations
  • CLIA Waivers
    • From advice to complete turn key services
  • EU IVDMD Compliance
    • CE Mark
    • Technical Files
  • Labeling and Advertising Review
  • FDA Representative/Official Correspondent
  • Compliance Crisis Management
    • FDA Warning Letters
    • Recall strategies and management
  • EU MDD Compliance
    • CE Marking
    • Technical Files

QUALITY SYSTEMS SERVICES

Our experience in technical aspects of device design, combined with our knowledge of the type of data collection and presentation that the FDA requires, give us powerful insights into the development pathways that will get you to market sooner. We can help resolve technical issues that the US FDA raises during reviews within the brief time period allowed for response.

  • US Good Manufacturing Practices
    • Turn key Systems Design
    • Analysis
    • Audit and Inspection
    • Complaint Handling
    • Corrective Action Plans
    • Assessments for Pre-Approval Inspections
    • SOPs, Documentation and Implementation
  • FDA Inspection Coordination
  • Vendor Audits
  • ISO/EN Standards
    • ISO 13485
    • ISO 9001/EN 46001
    • ISO 9001/EN 46002
    • Pre assessment audits
    • System design and documentation
    • ISO 14971 (Risk Analysis)
  • Training and Education Services
    • US Quality Systems Administration
      • US Good Manufacturing Practices
      • Quality Systems Regulations
    • Document Control Practices
    • Design Control
    • Planning for an FDA or ISO inspection
  • U.S. Agent/Official Correspondent Services
    • Annual Facility Registration & Device Listings
    • QSR/GMP & Regulatory Systems Auditing
    • 510(k) Submissions
    • Premarket Approvals
    • IDE Submissions Clinical Trial Management
    • FDA Inspection Coordination
    • Personnel Training
    • Strategic and Regulatory Planning