Key Quality Assurance Offerings
QUALITY SYSTEMS & PROCESSES
• Creating complete, new quality systems
• Gap assessments and streamlining of existing quality systems
• Updating quality systems for new regulations, standards, and guidance documents
• Validating quality system software (ERP, electronic signatures, temperature control, etc.)
AUDITS
• Mock FDA inspections (PMA pre-approval, routine, and for-cause)
• Internal audits for regulatory compliance
• Supplier audits for the quality of purchased goods and services
DEVICE DESIGN
• Leading and supporting design teams for new and updated Design History Files (DHFs)
• Validating manufacturing processes
• Creating and updating Risk Management files
• Remediating non-compliant DHFs and DMRs
BUSINESS NEEDS
• Due diligence of quality systems and DHFs prior to company or device acquisition
• Resolving quality deficiencies to improve a company’s or device’s value for acquisition
• Moving or combining manufacturing lines for acquisitions and facility upgrades
FDA-FACING SUPPORT
• Writing GMP Modules for PMA submissions
• Initiating and maintaining FDA recall activities
• Submitting Medical Device Reports (MDRs) to FDA
• Submitting Unique Device Identification (UDI) codes to FDA
• Submitting Establishment Registrations and Device Listings to FDA
OUS MARKETS
• Preparing for Notified Body and MDSAP audits
• Obtaining 13485:2016 certification
• Providing Quality support for Technical Documentation